Fundamentals of International Pharmaceutical and Biologics Regulations (Hardcover)

This book comprises the pharmaceutical and biologics chapters from International Fundamentals. It includes information on requirements, regulations and guidances specific to these products internationally, including an all-new chapter on pediatric drug development and more details on regional and country-specific requirements. This is an excellent reference book for those new to the drug or biologics field or more experienced professionals needing to check a quick fact. It also is a valuable study tool for those planning to sit for the RAC exam who are lacking substantial experience with pharmaceuticals and biologics, in addition to practical experience and other tools.

Table of Contents

• Chapter 1: Clinical Trials, Good Clinical Practice, Regulations and Compliance 1
• Chapter 2: International Advertising and Promotion 13
• Chapter 3: Premarket Requirements/Dossier Requirements 21
• Chapter 4: Authorization Procedures for Pharmaceutical Products 29
• Chapter 5: Stability Test Requirements 47
• Chapter 6: Quality Systems and Inspectorate Process for Pharmaceuticals 59
• Chapter 7: Generic Drug Products 75
• Chapter 8: Over-the-Counter (OTC) Products 89
• Chapter 9: Pharmaceutical Postmarketing and Compliance 97
• Chapter 10: High-Risk Products: Products Derived from Biotechnology 113
• Chapter 11: Biosimilars: Basics and Recent Developments 129
• Chapter 12: Vaccines 161
• Chapter 13: Products Manufactured From Human Blood and Plasma 179
• Chapter 14: Principles of Rare Diseases and Orphan Products Development 199
• Chapter 15: Global Pediatric Drug Development 209
• Comparative Matrix of the Regulations Across Product Lines 229
• Glossary 255
• Index 271