February 19, 2025

804 ET: Pharmaceutical Regulatory Science Syllabus, Notes, MCQ, books, PDF

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Pharmaceutical Regulatory Science Syllabus, Notes, MCQ, books, PDF


Unit I New Drug Discovery and development


Unit 1 MCQ New Drug Discovery and development MCQ


Unit II Regulatory Approval Process


Unit 2 MCQ Regulatory Approval Process MCQ


Unit III Registration of Indian drug products in the overseas market


Unit 3 MCQ Registration of Indian drug products in the overseas market MCQ


Unit IV Clinical trials


Unit 4 MCQ Clinical trials MCQ


Unit V Regulatory Concepts

Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book


Unit 5 MCQ Regulatory Concepts MCQ


Pharmaceutical Regulatory Science MCQ


Recommended books (Latest edition):

  1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
  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 / SandyWeinberg. 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. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
  7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams
  8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
  9. Drugs: From Discovery to Approval, Second Edition By Rick Ng

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

Suggested readings


Recommended readings: