Original price was: ₹5,472.81.₹4,378.25Current price is: ₹4,378.25.
Unlock essential insights into bioequivalence testing with the “Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)” by CRC Press. This indispensable second edition, updated for 2024, navigates the evolving landscape of generic drug development and regulatory requirements. Explore crucial updates on statistical models, analytical technology, and global guidelines. New topics delve into therapeutic code classifications, noninferiority models, biosimilarity of large molecules, and bioequivalence for complementary medicines and biosimilar therapeutic proteins. Discover revised FDA guidelines for bioanalytical method validation and strategies for outsourcing and monitoring. Essential for pharmaceutical professionals seeking to reduce development costs and accelerate generic drug approval, this handbook also critically examines the future of bioequivalence testing, proposing innovative approaches to biowaivers and reduced human studies. A vital resource for ensuring drug efficacy and navigating complex approval processes.
5 in stock
