Lawrence X. Yu,Bing V. Li's FDA Bioequivalence Standards (AAPS Advances in the PDF

By Lawrence X. Yu,Bing V. Li

ISBN-10: 1493912518

ISBN-13: 9781493912513

ISBN-10: 1493955586

ISBN-13: 9781493955589

This entire reference offers an in-depth dialogue on state of the art regulatory technology in bioequivalence. In 16 chapters, the amount explores a wide variety of subject matters referring to bioequivalence, together with its beginning and ideas, statistical issues, meals impact stories, stipulations for waivers of bioequivalence experiences, Biopharmaceutics class structures, Biopharmaceutics Drug Disposition type procedure, bioequivalence modeling/simulation and most sensible practices in bioanalysis. It additionally discusses bioequivalence reports with pharmacodynamic and medical endpoints in addition to bioequivalence techniques for hugely variable medicines, slender healing index medications, liposomes, in the community appearing gastrointestinal drug items, topical items and nasal and inhalation products.

FDA Bioequivalence Standards is written via FDA regulatory scientists who increase regulatory regulations and behavior regulatory evaluation of bioequivalence. As such, either sensible case experiences and basic technological know-how are highlighted in those chapters. The booklet is a precious source for scientists who paintings within the pharmaceutical undefined, regulatory businesses and academia in addition to undergraduate and graduate scholars trying to extend their wisdom approximately bioequivalence standards.

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FDA Bioequivalence Standards (AAPS Advances in the Pharmaceutical Sciences Series) by Lawrence X. Yu,Bing V. Li

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