Prediction of Bioequivalence of Generic Drug Products via In-vitro Tests: Via in-vitro Tests (Paperback) (ISBN-13: 9789347311260)

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.