Fundamentals of Biologicals Regulation

Name: Fundamentals of Biologicals Regulation
Price: 150 USD
Availability: InStock
ISBN: 9780443219887

Vaccines and Biotechnology Medicines

by Rebecca Sheets, Christopher Hamlin, Susan Neadle, Ivana Knezevic, Mark Schenerman, Mehmet Tosun, Kathryn C. Zoon

2nd Edition

Publisher: Academic Press

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Book Details

Print ISBN	9780443219887
eText ISBN	9780443219894
Publisher	Academic Press
Publishing Year	2026
Edition	2nd Edition
Language	English
Pages	618

Fundamentals of Biologicals Regulation, 2nd Edition, provides a comprehensive textbook structure focused on the global oversight of vaccines and biotechnology medicines. Designed for graduate students in regulatory affairs, regulatory science, biology, biotechnology, and engineering, the text establishes core concepts in biological product review, international convergence, and regulatory authorization.

The material progresses through the lifecycle of biological products, starting with discovery, preclinical pharmacology, and toxicology testing. Subsequent chapters investigate regulatory filings, including investigational new drug applications, marketing authorizations, and variations to approved products. Additional sections detail Quality by Design implementation, process validation, lot release analytics, and Good Practice compliance.

Updated case studies incorporate regulatory experiences from COVID-19 vaccine development and emergency authorization procedures to demonstrate application in urgent public health contexts. This edition supports academic instruction for prospective regulatory scientists while offering reference material for practicing biologicals regulators and developers of combination products.

Chapter 1: Introduction to the regulatory process for biologicals and to international regulatory convergence
Chapter 2: Discovery and development
Chapter 3: Communications and formal meetings with regulators
Chapter 4: Clinical trial authorization and investigational new drug applications
Chapter 5: Marketing authorization
Chapter 6: Alternative regulatory pathways and special programs
Chapter 7: Variations or changes to an approved application
Chapter 8: Good “X” Practices
Chapter 9: Audits and regulatory compliance inspections
Chapter 10: Preclinical safety and toxicology
Chapter 11: Preclinical pharmacology, proof‑of‑principle
Chapter 12: Institutional biosafety committees and regulation of genetically modified organisms
Chapter 13: Risk assessments
Chapter 14: Quality by design and product design, construction, development, manufacture, and process validation
Chapter 15: Lot release, analytics, and analytical validation
Chapter 16: Regulatory aspects of clinical trials
Chapter 17: Pharmacovigilance, safety reporting, and risk minimization
Chapter 18: Clinical trial ethics, human subjects protections, and the informed consent process
Chapter 19: Independent ethics committees and institutional review boards
Chapter 20: Biosimilars
Chapter 21: Cell and gene therapies
Chapter 22: In vitro diagnostics and biotech medical devices
Chapter 23: Combination products