About the Book:
Prediction of Bioequivalence of Generic Drug Products via In-Vitro Tests presents a comprehensive and systematic approach to one of the most critical challenges in pharmaceutical development—predicting bioequivalence outcomes. Rooted in the author’s extensive academic teaching and industry experience, including contributions at Dr. Reddy’s Laboratories and the establishment of a Centre of Excellence in Biostudies, this book bridges the gap between theory and real-world application.
The book guides readers from fundamental concepts of drug absorption and bioavailability to advanced methodologies such as biorelevant dissolution testing, IVIVC, reverse engineering of reference products, and designaround strategies. It provides practical insights and case studies that enable scientists to minimize failures in bioequivalence studies, reduce evelopment timelines, and meet regulatory expectations with confidence.
Contents:
1. Anatomy and Physiology of Gastro Intestinal Tract (GIT) and Drug Absorption
2. Reverse Engineering or Deformulation
3. Effect of Active Pharmaceutical Ingredient (API) and Other Factors on Drug Absorption
4. In-vitro Tests and their Significance
5. Biorelevant Media and Tests
6. How to Identify Right Test(s) for a given Drug Product?
7. In-Vitro In-Vivo Correlation
8. In-Vitro Tests for Bioequivalence
9. Biowaivers
10. Bioequivalence Studies
About the Author:
Dr. V. Venkateswarlu is a pharmaceutical scientist, US post-doctoral researcher, and former faculty member at the University College of Pharmaceutical Sciences, Kakatiya University. He has guided 12 Ph.D.
scholars and published around 80 National and International research papers with 15 patents. He is the author of Fundamentals of Biopharmaceutics and Pharmacokinetics.
