By Lawrence X. Yu, Bing V. Li
This complete reference presents an in-depth dialogue on state of the art regulatory technological know-how in bioequivalence. In 16 chapters, the amount explores a extensive diversity of issues bearing on bioequivalence, together with its foundation and rules, statistical concerns, nutrition impact reviews, stipulations for waivers of bioequivalence reports, Biopharmaceutics category platforms, Biopharmaceutics Drug Disposition type method, bioequivalence modeling/simulation and most sensible practices in bioanalysis. It additionally discusses bioequivalence experiences with pharmacodynamic and medical endpoints in addition to bioequivalence ways for hugely variable medications, slim healing index medicinal drugs, liposomes, in the community performing gastrointestinal drug items, topical items and nasal and inhalation products.
FDA Bioequivalence Standards is written through FDA regulatory scientists who increase regulatory guidelines and behavior regulatory evaluation of bioequivalence. As such, either useful case stories and primary technological know-how are highlighted in those chapters. The ebook is a important source for scientists who paintings within the pharmaceutical undefined, regulatory organizations and academia in addition to undergraduate and graduate scholars seeking to extend their wisdom approximately bioequivalence standards.