Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition
Table of Contents
Section I: General Information
- Chapter 1: The Drug Development Continuum, Preclinical to Market Access
- Chapter 2: International Harmonization via ICH, WHO, and Other Global Initiatives
Section II: Nonclinical Studies
- Chapter 3: Principles of Good Laboratory Practice and Nonclinical Development
- Chapter 4: Safety Pharmacology Studies
- Chapter 5: Pharmacokinetic and Toxicokinetic Studies
- Chapter 6: Acute and Chronic Toxicity Assessments
- Chapter 7: Local Tolerance Studies
- Chapter 8: Genotoxicity Studies
- Chapter 9: Carcinogenicity Studies
- Chapter 10: Developmental and Reproductive Toxicity Assessments
- Chapter 11: Regulatory Environmental Risk Assessment of Human Pharmaceuticals
Section III: Chemistry, Manufacturing, and Controls
- Chapter 12: The Global Regulatory Process for the Registration of Active Substances
- Chapter 13: Biologics and Small Molecules
- Chapter 14: Coordinating Drug Supply for Clinical and Nonclinical Development
- Chapter 15: Pharmaceutical Development Studies and Manufacturing Experience
- Chapter 16: Analytical Method Lifecycle: Management, Practice, and Regulatory Integration
Section IV: Clinical Trials
- Chapter 17: Conducting Clinical Trials: Drug Application Types, Data Requirements, and Obtaining Marketing Approval
- Chapter 18: Phases of Development (1, 2, 3, 4)
- Chapter 19: Enhancing Diversity in Clinical Trials
- Chapter 20: Health Authority Interactions
- Chapter 21: Pediatrics
- Chapter 22: Region-Specific Studies
Section V: Marketing Authorization
- Chapter 23: Core Labeling: An Important Global Tool
- Chapter 24: Framework for Benefit-Risk Assessment
- Chapter 25: eCTD and Digital Applications
- Chapter 26: Expedited Approval Pathways
- Chapter 27: Dossier Requirements
- Chapter 28: Combination Products
Section VI: Postmarketing Authorization
- Chapter 29: Postauthorization Commitments
- Chapter 30: Transfers and Renewals
- Chapter 31: Product Extensions, Variations, and Supplements
- Chapter 32: Compliance
- Chapter 33: Recalls
- Chapter 34: Postmarket Surveillance
- Chapter 35: Advertising and Promotion
- Chapter 36: Market Access: Reimbursement and Pricing
Linda McBride, RPh, RAC-US and Siegfried Schmitt, PhD, editors
About the Book
Available formats: print, e-book, and 3-year digital subscription
In today’s complex global regulatory landscape, critical information is often scattered across articles, chapters, and multiple languages, making it difficult to find clear, reliable guidance in one place. This fully updated second edition brings together that knowledge into a single, authoritative resource for regulatory professionals worldwide.
Building on the success of the first edition, this new release features 36 chapters, including expanded and updated content reflecting evolving global regulations. Developed by 61 expert authors and two lead editors, it offers a collaborative, global perspective you can trust.
New and expanded content addresses key emerging areas, including:
- Acute and Chronic Toxicity Assessments
- Local Tolerance Studies
- Core Labeling as a Global Tool
- Combination Products
While no single book can answer every question, this edition delivers one of the most comprehensive and practical collections of regulatory insight available today, helping you navigate challenges across the drug and biologics lifecycle with greater confidence.
Please note that print book orders may currently be delayed while we restock. We appreciate your patience!
Purchasing Options
This book can be purchased in the following formats:
- Pharmaceuticals and Biologics Fundamentals subscription.* A three-year subscription including the digital e-book version as well as automatic updates whenever a new edition and/or chapters are released during the subscription period.
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
- Regulatory Excellence Bundle: Fundamentals (subscription).* Includes the digital e-book subscription to:
- Fundamentals of Medical Device Regulations: A Global Perspective
- Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition
- Regulatory Excellence Bundle: Pharmaceutical and Biologics (subscription).* Includes the digital e-book subscription to:
- Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition
- Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
- Regulatory Intelligence Reimagined
- RAC exam test prep bundles
*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.
Published by RAPS © 2026. Hardcover. 666 pages. ISBN (print): 978-1-947493-96-4. ISBN (digital): 978-1-947493-97-1. Library of Congress Control Number: 2025948938.
