FDA Bioequivalence Standards

• Corporate Author: SpringerLink (Online service)
• Other Authors: Yu, Lawrence X. (Editor), Li, Bing V. (Editor)
• Format: Electronic eBook
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2014.
• Series: AAPS Advances in the Pharmaceutical Sciences Series, 13
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies,...

Table of Contents:

• 1 Bioequivalence History
• 2 Fundamentals of Bioequivalence
• 3 Basic Statistical Considerations
• 4 The Effects of Food on Drug Bioavailability and Bioequivalence
• 5 Bio waiver and Biopharmaceutics Classification System
• 6 Bioequivalence of Highly Variable Drugs
• 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
• 8 Bioequivalence for Narrow Therapeutic Index Drugs
• 9 Pharmacodynamic Endpoint-based Bioequivalence Studies
• 10 Clinical Endpoint Bioequivalence Study
• 11 Bioequivalence for Liposomal Drug Products
• 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
• 13 Bioequivalence for Topical Drug Products
• 14 Bioequivalence for Orally Inhaled and Nasal Drug Products
• 15 Bioequivalence: Modeling and Simulation
• 16 Bioanalysis.