Prediction of Bioequivalence of Generic Drug Products via In-vitro Tests: Via in-vitro Tests

V, Venkateswarlu

ISBN 10: 934731126X / ISBN 13: 9789347311260

Published by Pharmamed Press, 2026

About this Item

Seller Inventory # I-9789347311260

Bibliographic Details

• Title: Prediction of Bioequivalence of Generic Drug Products via In-vitro Tests: Via in-vitro Tests
• Publisher: Pharmamed Press
• Publication Date: 2026
• Language: English
• ISBN 10: 934731126X
• ISBN 13: 9789347311260
• Binding: Soft cover
• Condition: New

About this title

Synopsis

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.Written in a clear and lucid manner, this book is an essential resource for students, formulation scientists, biostudy professionals, and regulatory experts seeking a deeper understanding of predictive approaches in generic drug development.

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.He currently serves as Managing Director of Neuheit Pharma Technologies Pvt. Ltd., Hyderabad, focusing on complex generics, differentiated formulations, and bioequivalence studies for global markets. Earlier, he served as Vice President (R&D) at Dr. Reddy's Laboratories, leading QBD based pharmaceutical development.