By Lawrence X. Yu,Bing V. Li
This accomplished reference offers an in-depth dialogue on state of the art regulatory technology in bioequivalence. In 16 chapters, the quantity explores a extensive variety of themes bearing on bioequivalence, together with its starting place and ideas, statistical issues, nutrition impression reviews, stipulations for waivers of bioequivalence experiences, Biopharmaceutics category structures, Biopharmaceutics Drug Disposition class approach, bioequivalence modeling/simulation and most sensible practices in bioanalysis. It additionally discusses bioequivalence stories with pharmacodynamic and medical endpoints in addition to bioequivalence ways for hugely variable medicines, slender healing index medications, liposomes, in the community performing gastrointestinal drug items, topical items and nasal and inhalation products.
FDA Bioequivalence Standards is written by means of FDA regulatory scientists who advance regulatory regulations and behavior regulatory evaluation of bioequivalence. As such, either functional case reviews and basic technological know-how are highlighted in those chapters. The booklet is a beneficial 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.
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FDA Bioequivalence Standards (AAPS Advances in the Pharmaceutical Sciences Series) by Lawrence X. Yu,Bing V. Li