Revised Regulations for the Master of Pharmacy Degree Program, Exams of Nursing

Download Revised Regulations for the Master of Pharmacy Degree Program and more Exams Nursing in PDF only on Docsity! Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Revised Regulations for the Master of Pharmacy Degree Program (w.e.f. June 2016) Credit Based Semester System Pharmacy Council of India Combined Council's Building, Kotla Road, Aiwan-E-Ghalib Marg, New Delhi-110 002 4 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. maturity on the part of the learners. Learners are expected to follow the semester- wise schedule of courses given in the syllabus. 8. Academic work A regular record of attendance both in Theory, Practical, Seminar, Assignment, Journal club, Discussion with the supervisor, Research work presentation and Dissertation shall be maintained by the department / teaching staff of respective courses. 9. Course of study The specializations in M.Pharm program is given in Table I. Table – 1: List of M.Pharm. Specializations and their Code S. No. Specialization Code 1. Cosmeceutics MCC 2. Industrial Pharmacy MIP 3. Pharmaceutical Analysis MPA 4. Pharmaceutical Biotechnology MPB 5. Pharmaceutical Chemistry MPC 6. Pharmaceutics MPH 7. Pharmacognosy MPG 8. Pharmacology MPL 9. Pharmacy Practice MPP 10. Pharmaceutical Quality Assurance MQA 11. Pharmaceutical Regulatory Affairs MRA The course of study for M.Pharm specializations shall include Semester wise Theory & Practical as given in Table – II to XIII. The number of hours to be devoted to each theory and practical course in any semester shall not be less than that shown in Table – II to XIII. 5 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 2: Course of study for M. Pharm. (Cosmeceutics) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MCC101T Cosmeceuticals – Biology 4 4 4 100 MCC102T Cosmetics - Formulation Science 4 4 4 100 MCC103T Quality Assurance 4 4 4 100 MCC104T Cellular and Molecular Pharmacology 4 4 4 100 MCC105P Cosmeceutics Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MCC201T Cosmeceuticals 4 4 4 100 MCC202T Cosmetic Analysis and Evaluation 4 4 4 100 MCC203T Cosmectics- Industry and Regulatory 4 4 4 100 MCC204T Computer Aided Drug Delivery System 4 4 4 100 MCC205P Cosmeceutics Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 6 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 3: Course of study for M. Pharm. (Industrial Pharmacy) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MPA101T Modern Pharmaceutical Analytical Techniques 4 4 4 100 MIP101T Pharmaceutical Formulation Development 4 4 4 100 MIP102T Customized drug Delivery System 4 4 4 100 MIP103T Drug Regulations and Intellectual Property Rights 4 4 4 100 MIP104P Industrial Pharmacy Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MIP201T Advanced Biopharmaceutics and Pharmacokinetics 4 4 4 100 MIP202T Scale up and Technology Transfer 4 4 4 100 MIP203T Pharmaceutical Production Technology 4 4 4 100 MIP204T Entrepreneurship Management 4 4 4 100 MIP205P Industrial Pharmacy Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 9 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 6: Course of study for M. Pharm. (Pharmaceutical Chemistry) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MPA101T Modern Pharmaceutical Analytical Techniques 4 4 4 100 MPC101T Advanced Organic Chemistry -I 4 4 4 100 MPC102T Advanced Medicinal chemistry 4 4 4 100 MPC103T Chemistry of Natural Products 4 4 4 100 MPC104P Pharmaceutical Chemistry Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MPC201T Advanced Spectral Analysis 4 4 4 100 MPC202T Advanced Organic Chemistry -II 4 4 4 100 MPC203T Computer Aided Drug Design 4 4 4 100 MPC204T Pharmaceutical Process Chemistry 4 4 4 100 MPC205P Pharmaceutical Chemistry Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 10 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 7: Course of study for M. Pharm. (Pharmaceutics) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MPA101T Modern Pharmaceutical Analytical Techniques 4 4 4 100 MPH101T Modified Release Drug Delivery System 4 4 4 100 MPH102T Modern Pharmaceutics 4 4 4 100 MPH103T Pharmaceutical Regulatory Affair 4 4 4 100 MPH104P Pharmaceutics Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MPH201T Molecular Pharmaceutics(Nano Tech and Targeted DDS) 4 4 4 100 MPH202T Advanced Biopharmaceutics & Pharmacokinetics 4 4 4 100 MPH203T Computer Aided Drug Delivery System 4 4 4 100 MPH204T Cosmetic and Cosmeceuticals 4 4 4 100 MPH205P Pharmaceutics Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 11 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 8: Course of study for M. Pharm. (Pharmacognosy) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MPA101T Modern Pharmaceutical Analytical Techniques 4 4 4 100 MPG101T Advanced Pharmacognosy-1 4 4 4 100 MPG102T Phytochemistry 4 4 4 100 MPG103T Industrial Herbal drug technology 4 4 4 100 MPG104P Pharmacognosy Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MPG201T Medicinal Plant biotechnology 4 4 4 100 MPG102T Advanced Pharmacognosy-II 4 4 4 100 MPG203T Indian system of medicine 4 4 4 100 MPG204T Herbal cosmetics 4 4 4 100 MPG205P Pharmacognosy Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 14 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 11: Course of study for M. Pharm. (Pharmaceutical Quality Assurance) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MPA101T Modern Pharmaceutical Analytical Techniques 4 4 4 100 MQA101T Quality Management System 4 4 4 100 MQA102T Quality Control and Quality Assurance 4 4 4 100 MQA103T Product Development and Technology Transfer 4 4 4 100 MQA104P Pharmaceutical Quality Assurance Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MQA201T Hazards and Safety Management 4 4 4 100 MQA202T Pharmaceutical Validation 4 4 4 100 MQA203T Audits and Regulatory Compliance 4 4 4 100 MQA204T Pharmaceutical Manufacturing Technology 4 4 4 100 MQA205P Pharmaceutical Quality Assurance Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 15 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 12: Course of study for M. Pharm. (Pharmaceutical Regulatory Affairs) Course Code Course Credit Hours Credit Points Hrs./wk Marks Semester I MRA101T Good Pharmaceutical Practices 4 4 4 100 MRA102T Pharmaceutical Regulations in India 4 4 4 100 MRA103T International Pharmaceutical Regulations I 4 4 4 100 MRA104T Clinical Research Regulations 4 4 4 100 MRA105T Pharmaceutical Regulatory Affairs Practical I 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 Semester II MRA201T Documentation and Regulatory Writing 4 4 4 100 MRA202T Biologicals Regulations 4 4 4 100 MRA203T International Pharmaceutical Regulations II 4 4 4 100 MRA204T Medical Device Regulations 4 4 4 100 MRA205P Pharmaceutical Regulatory Affairs Practical II 12 6 12 150 - Seminar/Assignment 7 4 7 100 Total 35 26 35 650 16 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Table – 13: Course of study for M. Pharm. III Semester (Common for All Specializations) * Non University Exam Table – 14: Course of study for M. Pharm. IV Semester (Common for All Specializations) Course Code Course Credit Hours Credit Points - Journal Club 1 1 - Research Work 31 16 - Discussion/Final Presentation 3 3 Total 35 20 Table – 15: Semester wise credits distribution Semester Credit Points I 26 II 26 III 21 IV 20 Co-curricular Activities (Attending Conference, Scientific Presentations and Other Scholarly Activities) Minimum=02 Maximum=07* Total Credit Points Minimum=95 Maximum=100* *Credit Points for Co-curricular Activities Course Code Course Credit Hours Credit Points MRM101T Research Methodology and Biostatistics* 4 4 - Journal club 1 1 - Discussion / Presentation (Proposal Presentation) 2 2 - Research Work 28 14 Total 35 21 19 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 17: Schemes for internal assessments and end semester examinations (Cosmeceutics) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MCC101T Cosmeceuticals – Biology 10 15 1 Hr 25 75 3 Hrs 100 MCC102T Cosmetics - Formulation Science 10 15 1 Hr 25 75 3 Hrs 100 MCC103T Quality Assurance 10 15 1 Hr 25 75 3 Hrs 100 MCC104T Cellular and Molecular Pharmacology 10 15 1 Hr 25 75 3 Hrs 100 MCC105P Cosmeceutics Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MCC201T Cosmeceuticals 10 15 1 Hr 25 75 3 Hrs 100 MCC202T Cosmetic Analysis and Evaluation 10 15 1 Hr 25 75 3 Hrs 100 MCC203T Cosmectics- Industry and Regulatory 10 15 1 Hr 25 75 3 Hrs 100 MCC204T Computer Aided Drug Delivery System 10 15 1 Hr 25 75 3 Hrs 100 MCC201T Cosmeceuticals 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 20 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 18: Schemes for internal assessments and end semester examinations (Industrial Pharmacy) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MPA101T Modern Pharmaceutical Analytical Techniques 10 15 1 Hr 25 75 3 Hrs 100 MIP101T Pharmaceutical Formulation Development 10 15 1 Hr 25 75 3 Hrs 100 MIP102T Customized drug Delivery System 10 15 1 Hr 25 75 3 Hrs 100 MIP103T Drug Regulations and Intellectual Property Rights 10 15 1 Hr 25 75 3 Hrs 100 MIP104P Industrial Pharmacy Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MIP201T Advanced Biopharmaceutics and Pharmacokinetics 10 15 1 Hr 25 75 3 Hrs 100 MIP202T Scale up and Technology Transfer 10 15 1 Hr 25 75 3 Hrs 100 MIP203T Pharmaceutical Production Technology 10 15 1 Hr 25 75 3 Hrs 100 MIP204T Entrepreneurship Management 10 15 1 Hr 25 75 3 Hrs 100 MIP205P Industrial Pharmacy Practical II 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 21 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 19: Schemes for internal assessments and end semester examinations (Pharmaceutical Analysis) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MPA101T Modern Pharmaceutical Analysis 10 15 1 Hr 25 75 3 Hrs 100 MPA102T Advanced Pharmaceutical Analysis 10 15 1 Hr 25 75 3 Hrs 100 MPA103T Pharmaceutical Validation 10 15 1 Hr 25 75 3 Hrs 100 MPA104T Food Analysis 10 15 1 Hr 25 75 3 Hrs 100 MPA105P Pharmaceutical Analysis-I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MPA201T Advanced Instrumental Analysis 10 15 1 Hr 25 75 3 Hrs 100 MPA202T Modern Bio-Analytical Techniques 10 15 1 Hr 25 75 3 Hrs 100 MPA203T Quality Control and Quality Assurance 10 15 1 Hr 25 75 3 Hrs 100 MPA204T Cosmetic Analysis and Evaluation 10 15 1 Hr 25 75 3 Hrs 100 MPA205P Pharmaceutical Analysis-II 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 24 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 22: Schemes for internal assessments and end semester examinations (Pharmaceutics) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MPA101T Modern Pharmaceutical Analytical Techniques 10 15 1 Hr 25 75 3 Hrs 100 MPH101T Modified Release Drug Delivery System 10 15 1 Hr 25 75 3 Hrs 100 MPH102T Modern Pharmaceutics 10 15 1 Hr 25 75 3 Hrs 100 MPH103T Pharmaceutical Regulatory Affair 10 15 1 Hr 25 75 3 Hrs 100 MPH104P Pharmaceutics Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MPH201T Molecular Pharmaceutics(Nano Tech and Targeted DDS) 10 15 1 Hr 25 75 3 Hrs 100 MPH202T Advanced Biopharmaceutics & Pharmacokinetics 10 15 1 Hr 25 75 3 Hrs 100 MPH203T Computer Aided Drug Delivery System 10 15 1 Hr 25 75 3 Hrs 100 MPH204T Cosmetic and Cosmeceuticals 10 15 1 Hr 25 75 3 Hrs 100 MPH205P Pharmaceutics Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 25 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 23: Schemes for internal assessments and end semester examinations (Pharmacognosy) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MPA101T Modern Pharmaceutical Analytical Techniques 10 15 1 Hr 25 75 3 Hrs 100 MPG101T Advanced Pharmacognosy-1 10 15 1 Hr 25 75 3 Hrs 100 MPG102T Phytochemistry 10 15 1 Hr 25 75 3 Hrs 100 MPG103T Industrial Herbal drug technology 10 15 1 Hr 25 75 3 Hrs 100 MPG104P Pharmacognosy Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MPG201T Medicinal Plant biotechnology 10 15 1 Hr 25 75 3 Hrs 100 MPG102T Advanced Pharmacognosy-II 10 15 1 Hr 25 75 3 Hrs 100 MPG203T Indian system of medicine 10 15 1 Hr 25 75 3 Hrs 100 MPG204T Herbal cosmetics 10 15 1 Hr 25 75 3 Hrs 100 MPG205P Pharmacognosy Practical II 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 26 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 24: Schemes for internal assessments and end semester examinations (Pharmacology) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MPA101T Modern Pharmaceutical Analytical Techniques 10 15 1 Hr 25 75 3 Hrs 100 MPL101T Advanced Pharmacology-I 10 15 1 Hr 25 75 3 Hrs 100 MPL102T Pharmacological and Toxicological Screening Methods-I 10 15 1 Hr 25 75 3 Hrs 100 MPL103T Cellular and Molecular Pharmacology 10 15 1 Hr 25 75 3 Hrs 100 MPL104P Pharmacology Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MPL201T Advanced Pharmacology II 10 15 1 Hr 25 75 3 Hrs 100 MPL102T Pharmacological and Toxicological Screening Methods-II 10 15 1 Hr 25 75 3 Hrs 100 MPL203T Principles of Drug Discovery 10 15 1 Hr 25 75 3 Hrs 100 MPL204T Experimental Pharmacology practical- II 10 15 1 Hr 25 75 3 Hrs 100 MPL205P Pharmacology Practical II 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 29 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 27: Schemes for internal assessments and end semester examinations (Pharmaceutical Regulatory Affairs) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER I MRA101T Good Pharmaceutical Practices 10 15 1 Hr 25 75 3 Hrs 100 MRA102T Pharmaceutical Regulations in India 10 15 1 Hr 25 75 3 Hrs 100 MRA103T International Pharmaceutical Regulations I 10 15 1 Hr 25 75 3 Hrs 100 MRA104T Clinical Research Regulations 10 15 1 Hr 25 75 3 Hrs 100 MRA105T Pharmaceutical Regulatory Affairs Practical I 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 SEMESTER II MRA201T Documentation and Regulatory Writing 10 15 1 Hr 25 75 3 Hrs 100 MRA202T Biologicals Regulations 10 15 1 Hr 25 75 3 Hrs 100 MRA203T International Pharmaceutical Regulations II 10 15 1 Hr 25 75 3 Hrs 100 MRA204T Medical Device Regulations 10 15 1 Hr 25 75 3 Hrs 100 MRA205P Pharmaceutical Regulatory Affairs Practical II 20 30 6 Hrs 50 100 6 Hrs 150 - Seminar /Assignment - - - - - - 100 Total 650 30 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Tables – 28: Schemes for internal assessments and end semester examinations (Semester III& IV) Course Code Course Internal Assessment End Semester Exams Total MarksContinuous Mode Sessional Exams Total Marks DurationMarks Duration SEMESTER III MRM101T Research Methodology and Biostatistics* 10 15 1 Hr 25 75 3 Hrs 100 - Journal club - - - 25 - - 25 - Discussion / Presentation (Proposal Presentation) - - - 50 - - 50 - Research work* - - - - 350 1 Hr 350 Total 525 SEMESTER IV - Journal club - - - 25 - - 25 - Discussion / Presentation (Proposal Presentation) - - - 75 - - 75 - Research work and Colloquium - - - - 400 1 Hr 400 Total 500 *Non University Examination 31 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 11.2. Internal assessment: Continuous mode The marks allocated for Continuous mode of Internal Assessment shall be awarded as per the scheme given below. Table – 29: Scheme for awarding internal assessment: Continuous mode Theory Criteria Maximum Marks Attendance (Refer Table – 30) 8 Student – Teacher interaction 2 Total 10 Practical Attendance (Refer Table – 30) 10 Based on Practical Records, Regular viva voce, etc. 10 Total 20 Table – 30: Guidelines for the allotment of marks for attendance Percentage of Attendance Theory Practical 95 – 100 8 10 90 – 94 6 7.5 85 – 89 4 5 80 – 84 2 2.5 Less than 80 0 0 11.2.1. Sessional Exams Two sessional exams shall be conducted for each theory / practical course as per the schedule fixed by the college(s). The scheme of question paper for theory and practical sessional examinations is given below. The average marks of two sessional exams shall be computed for internal assessment as per the requirements given in tables – X. 12. Promotion and award of grades A student shall be declared PASS and eligible for getting grade in a course of M.Pharm.programme if he/she secures at least 50% marks in that particular courseincluding internal assessment. 13. Carry forward of marks In case a student fails to secure the minimum 50% in any Theory or Practical course as specified in 12, then he/she shall reappear for the end semester examination of that course. However his/her marks of the Internal Assessment shall be carried over and he/she shall be entitled for grade obtained by him/her on passing. 14. Improvement of internal assessment 34 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. on subsequent examination(s) theCGPA shall only reflect the new grade and not the fail grades earned earlier.The CGPA is calculated as: CGPA = C1S1 + C2S2 + C3S3 + C4S4 ------------------------------------------------------------------------- C1 + C2 + C3 + C4 where C1, C2, C3,…. is the total number of credits for semester I,II,III,…. and S1,S2, S3,….is the SGPA of semester I,II,III,…. . 20. Declaration of class The class shall be awarded on the basis of CGPA as follows: First Class with Distinction = CGPA of. 7.50 and above First Class = CGPA of 6.00 to 7.49 Second Class = CGPA of 5.00 to 5.99 21. Project work All the students shall undertake a project under the supervision of a teacher in Semester III to IV and submit a report. 4 copies of the project report shall be submitted (typed & bound copy not less than 75 pages). The internal and external examiner appointed by the University shall evaluate the project at the time of the Practical examinations of other semester(s). The projects shall be evaluated as per the criteria given below. 35 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Evaluation of Dissertation Book: Objective(s) of the work done 50 Marks Methodology adopted 150 Marks Results and Discussions 250 Marks Conclusions and Outcomes 50 Marks Total 500 Marks Evaluation of Presentation: Presentation of work 100 Marks Communication skills 50 Marks Question and answer skills 100 Marks Total 250 Marks 22. Award of Ranks Ranks and Medals shall be awarded on the basis of final CGPA. However, candidates who fail in one or more courses during the M.Pharm program shall not be eligible for award of ranks. Moreover, the candidates should have completed the M. Pharm program in minimum prescribed number of years, (two years) for the award of Ranks. 23. Award of degree Candidates who fulfill the requirements mentioned above shall be eligible for award of degree during the ensuing convocation. 24. Duration for completion of the program of study The duration for the completion of the program shall be fixed as double the actual duration of the program and the students have to pass within the said period, otherwise they have to get fresh Registration. 25. Revaluation I Retotaling of answer papers There is no provision for revaluation of the answer papers in any examination. However, the candidates can apply for retotaling by paying prescribed fee. 26. Re-admission after break of study Candidate who seeks re-admission to the program after break of study has to get the approval from the university by paying a condonation fee. 36 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. M. PHARM. PHARMACEUTICS (MPH) 39 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. DRUG DELIVERY SYSTEM (MPH101T) SCOPE This course is designed to impart knowledge on the area of advances in novel drug delivery systems. OBJECTIVES Upon completion of the course, student shall be able to understand  The various approaches for development of novel drug delivery systems.  The criteria for selection of drugs and polymers for the development of  The formulation and evaluation of Novel drug delivery systems.. THEORY 60 Hrs 10 Hrs 1. SR/CR formulation: Introduction & basic concepts, advantages/ disadvantages, factors influencing, Physicochemical & biological approaches for SR/CR formulation, Mechanism of Drug Delivery from SR/CR formulation. Polymers :introduction, definition, classification, properties and application Dosage Forms for Personalized Medicine: Introduction, Definition, Pharmacogenetics, Categories of Patients for Personalized Medicines: Customized drug delivery systems,Bioelectronic Medicines,3D printing of pharmaceuticals, Telepharmacy. 10 Hrs 2. Rate Controlled Drug Delivery Systems: Principles & Fundamentals, Types, Activation; Modulated Drug Delivery Systems;Mechanically activated, PH activated , Enzyme activated, and Osmotic activated Drug Delivery Systems Feedback regulated Drug Delivery Systems; Principles & Fundamentals . 3. Gastro-Retentive Drug Delivery Systems: Principle, concepts advantages and disadvantages, Modulation of GI transit time approaches to extend GI transit. Buccal Drug Delivery Systems: Principle of muco adhesion, advantages and disadvantages, Mechanism of drug permeation,Methods of formulation and its evaluations. 4. Occular Drug Delivery Systems: Barriers of drug permeation, Methods to overcome barriers. 10 Hrs 6 Hrs 5. Trans Dermal Drug Delivery Systems: Structure of skin and barriers, Penetration enhancers, Transdermal Drug Delivery Systems, Formulation and evaluation 10 Hrs 6. Protein and Peptide Delivery: Barriers for protein delivery. Formulation and Evaluation of delivery systems of proteins and other macromolecules. 40 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 8 Hrs 7. Vaccine delivery systems: Vaccines, uptake of antigens, single shot vaccines, mucosal and transdermal delivery of vaccines. 6 Hrs REFERENCES 1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker, Inc., New York, 1992. 2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,Inc., New York, 1992. 3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by WileyInterscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim 4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New Delhi, First edition 1997 (reprint in 2001). 5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances, Vallabh Prakashan, New Delhi, First edition 2002 JOURNALS 1. Indian Journal of Pharmaceutical Sciences (IPA) 2. Indian drugs (IDMA) 3. Journal of controlled release (Elsevier Sciences) desirable 4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable 41 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Scope MODERN PHARMACEUTICS (MPH102T) Course designed to impart advanced knowledge and skills required to learn various aspects and concepts at pharmaceutical industries Objectives Upon completion of the course, student shall be able to understand  To understand the elements of preformulation studies.  To understand the Active Pharmaceutical Ingredients and Generic drug Product development  To learn Industrial Management and GMP Considerations.  To understand Optimization Techniques & Pilot Plant Scale Up Techniques  To study Stability Testing, sterilization process & packaging of dosage forms. THEORY 60 HRS 10 hrs 1. Preformation Concepts – Drug Excipient interactions - different methods, kinetics of stability, Stability testing. Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS) preparation and stability Large and small volume parental – physiological and formulation consideration, Manufacturing and evaluation 10 Hrs 2. Optimization techniques in Pharmaceutical Formulation: Concept and parameters of optimization, Optimization techniques in pharmaceutical formulation and processing. Statistical design, Response surface method, Contour designs, Factorial designs and application in formulation. 10 Hrs 3. Validation : Introduction to Pharmaceutical Validation, Scope & merits of Validation, , Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipments, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities 10 Hrs 4. cGMP & Industrial Management: Objectives and policies of current good manufacturing practices, layout of buildings, services, equipments and their maintenance Production management: Production organization, , materials 44 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. CMC, post approval regulatory affairs.Regulation for combination products and medical devices.CTD and ECTD format, industry and FDA liaison. ICH - Guidelines of ICH-Q,S E,M. Regulatory requirements of EU, MHRA, TGA and ROW countries. 12 hrs 4. Non clinical drug development: Global submission of IND,NDA,ANDA.Investigation medicinal products dossier, dossier (IMPD) and investigator brochure (IB) 12 hrs 5. Clinical trials: Developing clinical trial protocols. Institutional review board/ independent ethics committee Formulation and working procedures informed Consent process and procedures. HIPAA- new, requirement to clinical study process, pharmacovigilance safety monitoring in clinical trials. 12 hrs REFERENCES 1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and IsaderKaufer,Marcel Dekker series, Vol.143 2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa Health care Publishers. 3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190. 4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.Inc. 5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics/edited By Douglas J. Pisano, David Mantus. 6. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A.Rozovsky and Rodney K. Adams 7. www.ich.org/ 8. www.fda.gov/ 9. europa.eu/index_en.htm 10. https://www.tga.gov.au/tga-basics 45 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PRACTICALS (MPH104P) 1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer 2.Simultaneous estimation of multi component containing formulations by UV spectrophotometry 3.Experiments based on HPLC 4.Experiments based on Gas Chromatography 5.Estimation of riboflavin/quinine sulphate by fluorimetry 6.Estimation of sodium/potassium by flame photometry 7. To perform In-vitro dissolution profile of CR/ SR marketed formulation 8.Formulation and evaluation of sustained release matrix tablets 9.Formulation and evaluation osmotically controlled DDS 10.Preparation and evaluation of Floating DDS- hydro dynamically balanced DDS 11.Formulation and evaluation of Muco adhesive tablets. 12.Formulation and evaluation of trans dermal patches. 13.To carry out preformulation studies of tablets. 14.To study the effect of compressional force on tablets disintegration time. 15.To study Micromeritic properties of powders and granulation. 16.To study the effect of particle size on dissolution of a tablet. 17.To study the effect of binders on dissolution of a tablet. 18.To plot Heckal plot, Higuchi and peppas plot and determine similarity factors. 46 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. MOLECULAR PHARMACEUTICS (NANO TECHNOLOGY & TARGETED DDS) (NTDS)(MPH201T) Scope This course is designed to impart knowledge on the area of advances in novel drug delivery systems. Objectives Upon completion of the course student shall be able to understand  The various approaches for development of novel drug delivery systems.  The criteria for selection of drugs and polymers for the development of NTDS  The formulation and evaluation of novel drug delivery systems. THEORY 60 Hrs 12 hrs 1. Targeted Drug Delivery Systems: Concepts, Events and biological process involved in drug targeting. Tumor targeting and Brain specific delivery. 12hrs 2. Targeting Methods: introduction preparation and evaluation. Nano Particles & Liposomes: Types, preparation and evaluation 12hrs 3. Micro Capsules / Micro Spheres: Types, preparation and evaluation , Monoclonal Antibodies ; preparation and application, preparation and application of Niosomes, Aquasomes, Phytosomes, Electrosomes. 12hrs 4. Pulmonary Drug Delivery Systems : Aerosols, propellents, ContainersTypes, preparation and evaluation, Intra Nasal Route Delivery systems; Types, preparation and evaluation 12hrs 5. Veterinary Drug Delivery Systems: Tablets and bolus, Feed additives, Drinking water medication, Oral paste and gels, Drenchers and Tubing product REFERENCES: 1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,Marcel 49 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.J aiswal., VallabPrakashan, Pitampura, Delhi 3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2ndedition, Connecticut Appleton Century Crofts, 1985 4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,Prism Book 5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,New York, 1982 6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Leaand Febiger, Philadelphia, 1970 7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by MalcolmRowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995 8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack PublishingCompany, Pennsylvania 1989 9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition,revised and expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,1987. 10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971. 11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan, Marcel Dekker Inc, New York, 1996. 12.Basic Pharmacokinetics,1 st edition,Sunil S JambhekarandPhilip J Breen,pharmaceutical press,RPS Publishing,2009. 13.Absorption and Drug Development- Solubility, Permeability, and Charge State, Alex Avdeef, John Wiley & Sons, Inc,2003. 50 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. COMPUTER AIDED DRUG DEVELOPMENT (MPH203T) Scope This course is designed to impart knowledge and skills necessary for computer Applications in pharmaceutical research and development who want to understand the application of computers across the entire drug research and development process. Basic theoretical discussions of the principles of more integrated and coherent use of computerized information (informatics) in the drug development process are provided to help the students’ to clarify the concepts. Objectives At completion of this course it is expected that students will be able to understand-  History of Computers in Pharmaceutical Research and Development  Computational Modeling of Drug Disposition  Computers in Preclinical Development  Optimization Techniques in Pharmaceutical Formulation  Computers in Market Analysis  Computers in Clinical Development  Artificial Intelligence (AI) and Robotics  Computational fluid dynamics(CFD) THEORY 60Hrs 1. Computers in Pharmaceutical Research and Development: A General Overview: History of Computers in Pharmaceutical Research and Development. Statistical modeling in Pharmaceutical research and development: Descriptive versus Mechanistic Modeling, Statistical Parameter ,Estimation, Confidence Regions, Nonlinearity at the Optimum, Sensitivity Analysis, Optimal Design, Population Modeling Quality-by-Design In Pharmaceutical Development: Introduction, ICH Q8 guideline, Regulatory and industry views on QbD, Scientifically based QbD - examples of application 12Hrs 2. Computational Modeling Of Drug Disposition: Introduction ,Modeling Techniques: Drug Absorption, Solubility, Intestinal Permeation, Drug Distribution ,Drug Excretion, Active Transport; P-gp, BCRP, Nucleoside Transporters, hPEPT1, ASBT, OCT, OATP, BBB-Choline Transporter. 12Hrs 51 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. Computer-aided formulation development:: Concept of optimization, Optimization parameters, Factorial design, Optimization technology & Screening design. Computers in Pharmaceutical Formulation: Development of pharmaceutical emulsions, microemulsion drug carriers Legal Protection of Innovative Uses of Computers in R&D, The Ethics of Computing in Pharmaceutical Research, Computers in Market analysis 12Hrs 4. Computer-aided biopharmaceutical characterization: Gastrointestinal absorption simulation Introduction, Theoretical background, Model construction, Parameter sensitivity analysis, Virtual trial, Fed vs. fasted state, In vitro dissolution and in vitro-in vivo correlation, Biowaiver considerations Computer Simulations in Pharmacokinetics and Pharmacodynamics: Introduction, Computer Simulation: Whole Organism, Isolated Tissues, Organs, Cell, Proteins and Genes. Computers in Clinical Development: Clinical Data Collection and Management, Regulation of Computer Systems 12Hrs 5. Artificial Intelligence (AI), Robotics and Computational fluid dynamics: General overview, Pharmaceutical Automation, Pharmaceutical applications, Advantages and Disadvantages. Current Challenges and Future Directions. 12Hrs REFERENCES: 1. Computer Applications in Pharmaceutical Research and Development, Sean Ekins, 2006, John Wiley & Sons. 2. Computer-Aided Applications in Pharmaceutical Technology, 1st Edition, Jelena Djuris, Woodhead Publishing 3. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan, Marcel Dekker Inc, New York, 1996. 54 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PRACTICAL (MPH205P) 1. To study the effect of temperature change , non solvent addition, incompatible polymer addition in microcapsules preparation 2. Preparation and evaluation of Alginate beads 3. Formulation and evaluation of gelatin /albumin microspheres 4. Formulation and evaluation of liposomes 5. Formulation and evaluation of niosomes 6. Formulation and evaluation of spheruls 7. Improvement of dissolution characteristics of slightly soluble drug by Solid dispersion technique. 8. Comparison of dissolution of two different marketed products /brands 9. Protein binding studies of a highly protein bound drug & poorly protein bound drug 10. Bioavailability studies of Paracetamol. 11. Pharmacokinetic and IVIVC data analysis by WinnolineR software 12. In vitro cell studies for permeability and metabolism 13. DoE Using Design Expert® Software 14. Formulation data analysis Using Design Expert® Software 15. Quality-by-Design in Pharmaceutical Development 16. Computer Simulations in Pharmacokinetics 17. Computer Simulations Pharmacodynamics 18. Computational Modeling Of Drug Disposition 19. To develop Clinical Data Collection manual 20. To carry out Sensitivity Analysis, and Population Modeling. 21. Development and evaluation of Creams 22. Development and evaluation of Shampoo and Toothpaste base 23. To Incorprate herbal and chemical actives to develop products 24. To address Dry skin, acne, blemish, Wrinkles, bleeding gums and dandruff 55 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. M. PHARM. PHARMACEUTICAL CHEMISTRY (MPC) 56 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. MODERN PHARMACEUTICAL ANALYSIS (MPA101T) Scope This subject deals with various advanced analytical instrumental techniques for identification, characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC, GC etc. Objectives After completion of course student is able to know,  The analysis of various drugs in single and combination dosage forms  Theoretical and practical skills of the instruments THEORY 60 HOURS 1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling, Instrumentation of Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies and Applications of IR spectroscopy Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers, Instrumentation and Applications of fluorescence spectrophotometer. Flame emission spectroscopy and Atomic absorption spectroscopy: Principle, Instrumentation, Interferences and Applications. 12 Hrs 2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy. 12 Hrs 3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and Applications of Mass spectroscopy 12 Hrs 59 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Aluminiumisopropoxide, N-bromosuccinamide, diazomethane, dicyclohexylcarbodimide, Wilkinson reagent, Witting reagent. Osmium tetroxide, titanium chloride, diazopropane, diethyl azodicarboxylate, Triphenylphosphine, Benzotriazol-1-yloxy) tris (dimethylamino) phosphonium hexafluoro-phosphate (BOP). Protecting groups a. Role of protection in organic synthesis b. Protection for the hydroxyl group, including 1,2-and1,3-diols: ethers, esters, carbonates, cyclic acetals & ketals c. Protection for the Carbonyl Group: Acetals and Ketals d. Protection for the Carboxyl Group: amides and hydrazides, esters e. Protection for the Amino Group and Amino acids: carbamates and amides 12Hrs 4. Heterocyclic Chemistry General methods of synthesis and applications of drugs of five, six membered and fused heterocylces such as imidazole, pyrazole, triazole, pyrimidine, quinoline, acridine, phenothiazine and purine. Synthesis of few representative drugs containing these heterocyclic nucleus 12Hrs 5. Synthon approach and retrosynthesis applications i. Basic principles, terminologies and advantages of retrosynthesis; guidelines for dissection of molecules. Functional group interconvertion and addition (FGI and FGA) ii. C‐X disconnections; C‐C disconnections – alcohols and carbonyl compounds; 1,2‐, 1,3‐,1,4‐, 1,5‐, 1,6‐difunctionalized compounds iii. Strategies for synthesis of three, four, five and six‐membered ring 12Hrs REFERENCES 1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J March, John Wiley and sons, New York. 2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart and Winston, NewYork. 3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford University Press 2001. 4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995. 5. A guide to mechanisms in Organic Chemistry – Peter Skyes (Orient Longman, New Delhi). 6. Reactive intermediates in organic chemistry – Tandom and Gowel. 60 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 7. Combinational Chemistry – Synthesis and applications – Stephen R Wilson & Anthony W Czarnik. 8. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.) 9. Organic synthesis-The disconnection approach, S. Warren, Wily India 10. Principles of organic synthesis, ROC Norman and JM Coxan, Nelson thorns 11. Organic synthesis- Special techniques VK Ahluwalia and R Agarwal, Narosa Publishers 12. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar, Narosa Publishers 61 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Scope ADVANCED MEDICINAL CHEMISTRY (MPC102T) The subject is designed to impart knowledge about recent advances in the field of medicinal chemistry at the molecular level including different techniques for the rational drug design. Objectives At completion of this course it is expected that students will be able to understand-  Different stages of drug discovery  Role of medicinal chemistry in drug research  Different techniques for drug discovery  Various strategies to design and develop new drug like molecules for biological targets  Peptidomimetics THEORY 60 Hrs 1. Drug discovery: Stages of drug discovery, lead discovery; identification, validation and diversity of drug targets. Chemistry of prostaglandins, leukotrienes and thromboxones. Biological drug targets: Receptors, types, binding and activation, theories of drug receptor interaction, drug receptor interactions, agonists vs antagonists, artificial enzymes. 12 Hrs 2. Prodrug Design and Analog design:  Prodrug design: Basic concept, Carrier linked prodrugs/ Bioprecursors, Prodrugs of functional group, Prodrugs to improve patient acceptability, Drug solubility, Drug absorption and distribution, site specific drug delivery and sustained drug action. Rationale of prodrug design and practical consideration of prodrug design.  Combating drug resistance: Causes for drug resistance, strategies to combat drug resistance in antibiotics and anticancer therapy, Genetic principles of drug resistance. 64 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Scope CHEMISTRY OF NATURAL PRODUCTS (MPC103T) The subject is designed to provide detail knowledge about chemistry of medicinal compounds from natural origin and general methods of structural elucidation of such compounds. It also emphasizes on isolation, purification and characterization of medicinal compounds from natural origin. Objectives At completion of this course it is expected that students will be able to understand-  Different types of natural compounds and their chemistry and medicinal importance  The importance of natural compounds as lead molecules for new drug discovery  The concept of rDNA technology tool for new drug discovery  General methods of structural elucidation of compounds of natural origin  Isolation, purification and characterization of simple chemical constituents from natural source THEORY 60 Hrs 1. Study of Natural products as leads for new pharmaceuticals for the following class of drugs: a. Drugs Affecting the Central Nervous System: Morphine Alkaloids b. Anticancer Drugs: Paclitaxel and Docetaxel, Etoposide, and Teniposide c. Cardiovascular Drugs: Lovastatin, Teprotide and Dicoumarol d. Neuromuscular Blocking Drugs: Curare alkaloids e. Chemistry of macrolid antibiotics: Erythromycine, Azithromycine, Cephalosporins(New generation) 12Hrs 2. Alkaloids- General introduction, classification, isolation, purification, stereochemistry, molecular modification and biological activity of alkaloids, general methods of structural determination of alkaloids, structural elucidation of ephedrine, morphine, ergot, emetine and reserpine. Flavonoids. Introduction, isolation and purification of flavonoids, General methods of structural determination of flavonoids; Structural elucidation of quercetin. 12Hrs 3. Steroids- General introduction, chemistry of sterols, sapogenin and cardiac glycosides. Stereochemistry and nomenclature of steroids, Structure elucidation of 65 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. male & female sex hormones( testosterone, Estradial, progesterone), Adrenocortcoids (carsisone) and contraceptive agents. Terpenoids – Classification, isolation, isoprene rule and general methods of structural elucidation of Terpenoids; Structural elucidation of drugs belonging to mono, di and tri terpenoids, carotinoids. 12Hrs 4. Recombinant DNA technology and drug discovery: rDNA technology, hybridoma technology, New pharmaceuticals derived from biotechnology; Oligonucleotide therapy. Gene therapy: Introduction, Clinical application and recent advances in gene therapy, principles of RNA & DNA estimation Active constituent of certain crude drugs used in Indigenous system. Diabetic therapy – Gymnema sylvestre, Salacia reticulate, Pterocarpus marsupiam, Swertia chirata, Trigonella foenum graccum; Liver dysfunction – Phyllanthus niruri; Antitumor – Curcuma longa Linn. 12Hrs 5. Structural Characterization of natural Products Structural characterization of natural compounds using IR, 1HNMR, 13CNMR and MS Spectroscopy 12Hrs REFERENCES 1. Modern methods of plant analysis – Peech and M.V.Tracey. 2. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld. 3. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles. 4. Chemistry of natural products Vol I onwards IWPAC. 5. Natural Product Chemistry Nakanishi Gggolo. 6. Natural Product Chemistry “A laboratory guide” – Rapheal Khan. 7. The Alkaloid Chemistry and Physiology by THF Manske. 8. Introduction to molecular Phytochemistry – CHJ Wells, Chapmannstall. 9. Organic Chemistry of Natural Products Vol I and II by Gurdeep and Chatwall. 10. Organic Chemistry of Natural Products Vol I and II by O.P. Agarwal. 11. Organic Chemistry Vol I and II by I.L. Finar 12. Elements of Biotechnology by P.K. Gupta. 13. Pharmaceutical Biotechnology by S.P.Vyas and V.K.Dixit. 14. Biotechnology by Purohit and Mathoor. 15. Phytochemical methods of Harborne. 16. Burger’s Medicinal Chemistry. 66 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PRACTICALS (MPC104P) 1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer, RNA & DNA estimation 2. Simultaneous estimation of multi component containing formulations by UV spectrophotometry 3. Experiments based on HPLC 4. Experiments based on Gas Chromatography 5. Estimation of riboflavin/quinine sulphate by fluorimetry 6. Estimation of sodium/potassium by flame photometry To perform the following reactions of synthetic importance 7. Purification of organic solvents, column chromatography 8. Claisen-schimidt reaction. 9. Benzyllic acid rearrangement. 10. Beckmann rearrangement. 11. Hoffmann rearrangement 12. Mannich reaction 13. Synthesis of medicinally important compounds involving more than one step along with purification and Characterization using TLC, melting point and IR spectroscopy (4 experiments) 14. Estimation of elements and functional groups in organic natural compounds 15. Isolation, characterization like melting point, mixed melting point, molecular weight determination, functional group analysis, co-chromatographic technique for identification of isolated compounds and interpretation of UV and IR data. 16. Some typical degradation reactions to be carried on selected plant constituents 69 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. ADVANCED ORGANIC CHEMISTRY -II(MPC202T) Scope The subject is designed to provide in-depth knowledge about advances in organic chemistry, different techniques of organic synthesis and their applications to process chemistry as well as drug discovery. Objectives Upon completion of course, the student shall able to understand  The principles and applications of Green chemistry  The concept of peptide chemistry.  The various catalysts used in organic reactions  The concept of stereochemistry and asymmetric synthesis. THEORY 60 Hrs 1. Green Chemistry a. Introduction, principles of green chemistry b. Microwave assisted reactions: Merit and demerits of its use, increased reaction rates, mechanism, superheating effects of microwave, effects of solvents in microwave assisted synthesis, microwave technology in process optimization, its applications in various organic reactions and heterocycles synthesis c. Ultrasound assisted reactions: Types of sonochemical reactions, homogenous, heterogeneous liquid-liquid and liquid-solid reactions, synthetic applications d. Continuous flow reactors: Working principle, advantages and synthetic applications. 12Hrs 2. Chemistry of peptides a. Coupling reactions in peptide synthesis b. Principles of solid phase peptide synthesis, t-BOC and FMOC protocols, various solid supports and linkers: Activation procedures, peptide bond formation, deprotection and cleavage from resin, low and high HF cleavage protocols, formation of free peptides and peptide amides, purification and case studies, site-specific chemical modifications of peptides c. Segment and sequential strategies for solution phase peptide synthesis with any two case studies d. Side reactions in peptide synthesis: Deletion peptides, side reactions initiated by proton abstraction, protonation, over-activation and side reactions of individual amino acids. 12Hrs 70 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. Photochemical Reactions Basic principles of photochemical reactions. Photo-oxidation, photo-addition and photo-fragmentation Pericyclic reactions Mechanism, Types of pericyclic reactions such as cyclo addition, elctrocyclic reaction and sigmatrophic rearrangement reactions with examples 12Hrs 4. Catalysis a. Types of catalysis, heterogeneous and homogenous catalysis, advantages and disadvantages b. Heterogeneous catalysis – preparation, characterization, kinetics, supported catalysts, catalyst deactivation and regeneration, some examples of heterogeneous catalysis used in synthesis of drugs. c. Homogenous catalysis, hydrogenation, hydroformylation, hydrocyanation, Wilkinson catalysts, chiral ligands and chiral induction, Ziegler‐Natta catalysts, some examples of homogenous catalysis used in synthesis of drugs d. Transition-metal and Organo-catalysis in organic synthesis: Metal-catalyzed reactions e. Biocatalysis: Use of enzymes in organic synthesis, immobilized enzymes/cells in organic reaction. f. Phase transfer catalysis ‐ theory and applications 12Hrs 5. Stereochemistry & Asymmetric Synthesis a. Basic concepts in stereochemistry – optical activity, specific rotation, racemates and resolution of racemates, the Cahn, Ingold, Prelog (CIP) sequence rule, meso compounds, pseudo asymmetric centres, axes of symmetry, Fischers D and L notation, cis-trans isomerism, E and Z notation. b. Methods of asymmetric synthesis using chiral pool, chiral auxiliaries and catalytic asymmetric synthesis, enantiopure separation and Stereo selective synthesis with examples. 12Hrs REFERENCES 1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J March, John Wiley and sons, New York. 2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart and Winston,NewYork. 71 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford University Press 2001. 4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995. 5. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.) 6. Organic synthesis-the disconnection approach, S. Warren, Wily India 7. Principles of organic synthesis, ROCNorman and JMCoxan, Nelson thorns 8. Organic synthesis- Special techniques VK Ahluwalia and R Aggarwal, Narosa Publishers 9. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar, Narosa Publishers 74 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PHARMACEUTICAL PROCESS CHEMISTRY (MPC204T) Scope Process chemistry is often described as scale up reactions, taking them from small quantities created in the research lab to the larger quantities that are needed for further testing and then to even larger quantities required for commercial production. The goal of a process chemist is to develop synthetic routes that are safe, cost-effective, environmentally friendly, and efficient. The subject is designed to impart knowledge on the development and optimization of a synthetic route/s and the pilot plant procedure for the manufacture of Active Pharmaceutical Ingredients (APIs) and new chemical entities (NCEs) for the drug development phase. Objectives At completion of this course it is expected that students will be able to understand-  The strategies of scale up process of apis and intermediates  The various unit operations and various reactions in process chemistry THEORY 60 Hrs 1. Process chemistry a. Introduction, Synthetic strategy b. Stages of scale up process: Bench, pilot and large scale process. c. In-process control and validation of large scale process. d. Case studies of some scale up process of APIs. e. Impurities in API, types and their sources including genotoxic impurities 12 Hrs 2. Unit operations a. Extraction: Liquid equilibria, extraction with reflux, extraction with agitation, counter current extraction. b. Filtration: Theory of filtration, pressure and vacuum filtration, centrifugal filtration, c. Distillation: azeotropic and steam distillation d. Evaporation: Types of evaporators, factors affecting evaporation. e. Crystallization: Crystallization from aqueous, non-aqueous solutions factors affecting crystallization, nucleation. Principle and general methods of Preparation of polymorphs, hydrates, solvates and amorphous APIs. 12 Hrs 75 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. Unit Processes a. Nitration: Nitrating agents, Aromatic nitration, kinetics and mechanism of aromatic nitration, process equipment for technical nitration, mixed acid for nitration, b. Halogenation: Kinetics of halogenations, types of halogenations, catalytic halogenations. Case study on industrial halogenation process. c. Oxidation: Introduction, types of oxidative reactions, Liquid phase oxidation with oxidizing agents. Nonmetallic Oxidizing agents such as H2O2, sodium hypochlorite, Oxygen gas, ozonolysis. 12 Hrs 4. Unit Processes a. Reduction: Catalytic hydrogenation, Heterogeneous and homogeneous catalyst; Hydrogen transfer reactions, Metal hydrides. Case study on industrial reduction process. b. Fermentation: Aerobic and anaerobic fermentation. Production of i. Antibiotics; Penicillin and Streptomycin, ii. Vitamins: B2 and B12 iii. Statins: lovastatin, simvastatin Reaction progress kinetic analysis a. Streamlining reaction steps, route selection, b. Characteristics of expedient routes, characteristics of cost-effective routes, reagent selection, families of reagents useful for scale-up. 12 Hrs 5. Industrial Safety a. MSDS (Material Safety Data Sheet), hazard labels of chemicals and Personal Protection Equipment (PPE) b. Fire hazards, types of fire & fire extinguishers c. Occupational Health & Safety Assessment Series 1800 (OHSAS-1800) and ISO-14001(Environmental Management System), Effluents and its management 12 Hrs REFERENCES: 1. Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever- Changing Climate-An Overview; K. Gadamasetti 2. Pharmaceutical Manufacturing Encyclopedia, 3rd edition, Volume 2. 3. Medicinal Chemistry by Burger, 6th edition, Volume 1-8. 76 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 4. W.L. McCabe, J.C Smith, Peter Harriott. Unit operations of chemical engineering, 7th edition, McGraw Hill 5. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed: H G Brittain (1999) 6. Regina M. Murphy: Introduction to Chemical Processes: Principles, Analysis, Synthesis 7. Peter J. Harrington: Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up 8. P.H.Groggins: Unit processes in organic synthesis (MGH) 9. F.A.Henglein: Chemical Technology (Pergamon) 10. M.Gopal: Dryden’s Outlines of Chemical Technology 11. Clausen,Mattson: Principle of Industrial Chemistry 12. Lowenheim & M.K. Moran: Industrial Chemicals 13. S.D. Shukla & G.N. Pandey: A text book of Chemical Technology Vol. II 14. J.K. Stille: Industrial Organic Chemistry (PH) 15. Srreve: Chemical Procress 16. B.K.Sharma: Industrial Chemistry 17. ICH Guidelines 18. United States Food and Drug Administration official website www.fda.gov 79 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PHARMACOLOGY (MPC) 80 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. SEMISTER I 1. MODERN PHARMACEUTICAL ANALYSIS 2. ADVANCED PHARMACOLOGY-I 3. PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-I 4. CELLULAR AND MOLECULAR PHARMACOLOGY Practicals SEMISTER I 1. ADVANCED PHARMACOLOGY-II 2. TOXICOLOGICAL SCREENING METHODS 3. PRINCIPLES OF DRUG DISCOVERY 4. CLINICAL RESEARCH AND PHARMACOVIGILANCE 5. EXPERIMENTAL PHARMACOLOGY-II Practicals *Soft skills should be added in research methodology and biostatistics paper in semester III *Practical in Modern pharmaceutical with emphasis on analysis case study 81 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. MODERN PHARMACEUTICAL ANALYSIS (MPA101T) Scope This subject deals with various advanced analytical instrumental techniques for identification, characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC, GC etc. Objectives After completion of course student is able to know,  The analysis of various drugs in single and combination dosage forms  Theoretical and practical skills THEORY 60 HOURS 1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated with UV-Visible spectroscopy, Choice of solvents and solvent effect and Applications of UV-Visible spectroscopy. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling, Instrumentation of Dispersive and Fourier - Transform IR Spectrometer, Factors affecting vibrational frequencies and Applications of IR spectroscopy Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence, Quenchers, Instrumentation and Applications of fluorescence spectrophotometer. Flame emission spectroscopy and Atomic absorption spectroscopy: Principle, Instrumentation, Interferences and Applications. 12 Hrs 2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR. Applications of NMR spectroscopy. 12 Hrs 3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic peaks and Applications of Mass spectroscopy 12 Hrs 84 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. a. Autonomic Pharmacology Parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting neuromuscular junction UNIT-III 12 Hrs Central nervous system Pharmacology General and local anesthetics 02 hrs Sedatives and hypnotics, drugs used to treat anxiety. 02 hrs Depression, psychosis, mania, epilepsy, neurodegenerative diseases. 05 hrs Narcotic and non-narcotic analgesics. 03 hrs UNIT-IV Cardiovascular Pharmacology 12 Hrs Diuretics, antihypertensives, antiischemics, anti- arrhythmics, drugs for heart failure and hyperlipidemia. 07 hrs Hematinics, coagulants , anticoagulants, fibrinolytics and anti-platelet drugs 05 hrs UNIT- V Autocoid Pharmacology 12 Hrs The physiological and pathological role of Histamine, Serotonin, Kinins Prostaglandins Opioid autocoids. 08 hrs Pharmacology of antihistamines, 5HT antagonists. 04 hrs REFEERENCES 1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s 2. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David E Golan et al. 3. Basic and Clinical Pharmacology by B.G -Katzung 4. Pharmacology by H.P. Rang and M.M. Dale. 6. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott. 6. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley. 7. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu. 8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists 85 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-I (MPL102T) Scope This subject is designed to impart the knowledge on preclinical evaluation of drugs and recent experimental techniques in the drug discovery and development. The subject content helps the student to understand the maintenance of laboratory animals as per the guidelines, basic knowledge of various in-vitro and in-vivo preclinical evaluation processes Objectives Upon completion of the course the student shall be able to,  Appraise the regulations and ethical requirement for the usage of experimental animals.  Describe the various animals used in the drug discovery process and good laboratory practices in maintenance and handling of experimental animals  Describe the various newer screening methods involved in the drug discovery process  Appreciate and correlate the preclinical data to humans THEORY 60 HOURS Unit-I 12 Hrs Laboratory Animals Common lab animals: Description, handling and applications of different species and strains of animals. 02 hrs Transgenic animals: Production, maintenance and applications 02 hrs Anaesthesia and euthanasia of experimental animals. 03 hrs Maintenance and breeding of laboratory animals. 02 hrs CPCSEA guidelines to conduct experiments on animals 02 hrs Good laboratory practice. 01 hrs Unit-II 12 Hrs Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. General principles of preclinical screening. CNS Pharmacology: behavioral and muscle co ordination, CNS stimulants and depressants, anxiolytics, anti-psychotics, anti epileptics 86 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. and nootropics. Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers and multiple sclerosis. Drugs acting on Autonomic Nervous System. Unit-III 12 Hrs Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Respiratory Pharmacology: anti-asthmatics, drugs for COPD and anti allergics. Reproductive Pharmacology: Aphrodisiacs and antifertility agents Analgesics, antiinflammatory and antipyretic agents. Gastrointestinal drugs: anti ulcer, anti -emetic, anti-diarrheal and laxatives. Unit-IV 12 hrs Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Cardiovascular Pharmacology: antihypertensives, antiarrythmics, antianginal, antiatherosclerotic agents and diuretics. Drugs for metabolic disorders like anti- diabetic, antihyperlipidemic, and agents. Anti cancer agents Unit V 12 hrs Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Immunosuppressants and immunomodulators 02 hrs General principles of immunoassay: theoretical basis and optimization of immunoassay, heterogeneous and homogenous immunoassay systems. Immunoassay methods evaluation; protocol outline, objectives and preparation. Immunoassay for digoxin and insulin 08 hrs Limitations of animal experimentation and alternate animal experiments. 01 hr Extrapolation of in vitro data to preclinical and preclinical to humans. 01 hr REFERENCES 1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin 2. Indian Pharmacopeia and other Pharmacopeias 3. Screening methods in Pharmacology by Robert Turner. A 4. Evaluation of drugs activities by Laurence and Bachrach 89 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. DNA electrophoresis, PCR (reverse transcription and real time), Gene sequencing, micro array technique, SDS page, ELISA and western blotting, Recombinant DNA technology and gene therapy 06 hrs Basic principles of recombinant DNA technology-Restriction enzymes, various types of vectors. Applications of recombinant DNA technology. Gene therapy- Various types of gene transfer techniques, clinical applications and recent advances in gene therapy Unit IV 12Hrs Pharmacogenomics 08 hrs Gene mapping and cloning of disease gene. Genetic variation and its role in health/ pharmacology Polymorphisms affecting drug metabolism Genetic variation in drug transporters Genetic variation in G protein coupled receptors Applications of proteomics science: Genomics, proteomics, metabolomics, functionomics, nutrigenomics Immunotherapeutics 04 hrs Types of immunotherapeutics, humanisation antibody therapy, Immunotherapeutics in clinical practice Unit V 12Hrs Cell culture techniques Basic equipments used in cell culture lab. Cell culture media, various types of cell culture, general procedure for cell cultures; isolation of cells, subculture, cryopreservation, characterization of cells and their application. Principles and applications of cell viability assays, glucose uptake assay, Calcium influx assays Principles and applications of flow cytometry Unit VI Biosimilars References: 1. The Cell, A Molecular Approach. Geoffrey M Cooper. 2. Pharmacogenomics: The Search for Individualized Therapies. Edited by J. Licinio and M -L. Wong 90 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 3. Handbook of Cell Signaling (Second Edition) Edited by Ralph A. et.al 4. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson et.al 5. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller 6. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor) 7. Animal Cell Culture: A Practical Approach by John R. Masters (Editor) 8. Current porotocols in molecular biology vol I to VI edited by Frederick M.Ausuvel et la. Experimental Pharmacology- I (MPL104P) 1.Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer 2.Simultaneous estimation of multi component containing formulations by UV spectrophotometry 3.Experiments based on HPLC 4.Experiments based on Gas Chromatography 5.Estimation of riboflavin/quinine sulphate by fluorimetry 6.Estimation of sodium/potassium by flame photometry Handling of laboratory animals. 1. Various routes of drug administration. 2. Techniques of blood sampling, anesthesia and euthanasia of experimental animals. 3. Functional observation battery tests (modified Irwin test) 4. Evaluation of CNS stimulant, depressant, anxiogenics and anxiolytic, anticonvulsant activity. 5. Evaluation of analgesic, anti-inflammatory, local anesthetic, mydriatic and miotic activity. 6. Evaluation of diuretic activity. 7. Evaluation of antiulcer activity by pylorus ligation method. 8. Oral glucose tolerance test. 9. Isolation and identification of DNA from various sources (Bacteria, Cauliflower, onion, Goat liver). 10. Isolation of RNA from yeast 11. Estimation of proteins by Braford/Lowry’s in biological samples. 12. Estimation of RNA/DNA by UV Spectroscopy 13. Gene amplification by PCR. 14. Protein quantification Western Blotting. 15. Enzyme based in-vitro assays (MPO, AChEs, α amylase, α glucosidase). 16. Cell viability assays (MTT/Trypan blue/SRB). 17. DNA fragmentation assay by agarose gel electrophoresis. 91 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. 18. DNA damage study by Comet assay. 19. Apoptosis determination by fluorescent imaging studies. 20. Pharmacokinetic studies and data analysis of drugs given by different routes of administration using softwares 21. Enzyme inhibition and induction activity 22. Extraction of drug from various biological samples and estimation of drugs in biological fluids using different analytical techniques (UV) 23. Extraction of drug from various biological samples and estimation of drugs in biological fluids using different analytical techniques (HPLC) References 1. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA guidelines, 2. Fundamentals of experimental Pharmacology by M.N.Ghosh 3. Handbook of Experimental Pharmacology by S.K. Kulkarni. 4. Drug discovery and Evaluation by Vogel H.G. 5. Spectrometric Identification of Organic compounds - Robert M Silverstein, 6. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 7. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset, Mendham, Denney, 8. Basic Cell Culture protocols by Cheril D. Helgason and Cindy L.Mille 9. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor) 10. Animal Cell Culture: A Practical Approach by John R. Masters (Editor) 94 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. TOXICOLOGICAL SCREENING METHODS (MPL202T) Scope: The subject imparts knowledge on the preclinical safety and toxicological evaluation of drug & new chemical entity. This knowledge will make the student competent in regulatory toxicological evaluation. Objectives: Upon completion of the course, the student shall be able to,  Explain the various types of toxicity studies.  Appreciate the importance of ethical and regulatory requirements for toxicity studies.  Demonstrate the practical skills required to conduct the preclinical toxicity studies. Unit I 12 Hrs Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive) Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y OECD principles of Good laboratory practice (GLP) History, concept and its importance in drug development Unit II 12 Hrs Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD guidelines. Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies. Test item characterization- importance and methods in regulatory toxicology studies Unit III 12 Hrs Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenecity studies (segment II) Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus and Chromosomal aberrations studies) In vivo carcinogenicity studies Unit IV 12 Hrs IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission. Safety pharmacology studies- origin, concepts and importance of safety pharmacology. Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal and other studies 95 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. Unit V 12 Hrs Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing. REFERENCES 1. Hand book on GLP, Quality practices for regulated non-clinical research and development (http://www.who.int/tdr/publications/documents/glp-handbook.pdf). 2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules, 2005, ministry of health and family welfare (department of health) New Delhi 3. Drugs from discovery to approval by Rick NG. 4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan 5. OECD test guidelines. 6. Principles of toxicology by Karen E. Stine, Thomas M. Brown. 7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/g uidances/ucm073246.pdf) 96 Revised Regulations for the Master of Pharmacy Degree Program Latest Update. PRINCIPLES OF DRUG DISCOVERY (MPL203T) Scope: The subject imparts basic knowledge of drug discovery process. This information will make the student competent in drug discovery process Objectives: Upon completion of the course, the student shall be able to,  Explain the various stages of drug discovery.  Appreciate the importance of the role of genomics, proteomics and bioinformatics in drug discovery  Explain various targets for drug discovery.  Explain various lead seeking method and lead optimization  Appreciate the importance of the role of computer aided drug design in drug discovery Unit-I 12 Hrs An overview of modern drug discovery process: Target identification, target validation, lead identification and lead Optimization. Economics of drug discovery. Target Discovery and validation-Role of Genomics, Proteomics and Bioinformatics. Role of Nucleic acid microarrays, Protein microarrays, Antisense technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins. Role of transgenic animals in target validation. Unit-II 12 Hrs Lead Identification- combinatorial chemistry & high throughput screening, in silico lead discovery techniques, Assay development for hit identification. Protein structure Levels of protein structure, Domains, motifs, and folds in protein structure. Computational prediction of protein structure: Threading and homology modeling methods. Application of NMR and X-ray crystallography in protein structure prediction Unit-III 12 Hrs Rational Drug Design Traditional vs rational drug design, Methods followed in traditional drug design, High throughput screening, Concepts of Rational Drug Design, Rational Drug Design Methods: Structure and Pharmacophore based approaches Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore mapping and pharmacophore based Screening,