| 书目名称 | FDA Bioequivalence Standards | | 编辑 | Lawrence X. Yu,Bing V. Li | | 视频video | http://file.papertrans.cn/341/340036/340036.mp4 | | 概述 | Covers the fundamentals as well as the most up-to-date progress in bioequivalence standards, which are critical to new and generic development and regulation.Discusses the current best practices in bi | | 丛书名称 | AAPS Advances in the Pharmaceutical Sciences Series | | 图书封面 |  | | 描述 | .This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products..FDA Bioequivalence Standards. is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters.. .The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as under | | 出版日期 | Book 2014 | | 关键词 | ANDA; bioequivalence; narrow therapeutic window index drugs; regulations; simulation | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4939-1252-0 | | isbn_softcover | 978-1-4939-5558-9 | | isbn_ebook | 978-1-4939-1252-0Series ISSN 2210-7371 Series E-ISSN 2210-738X | | issn_series | 2210-7371 | | copyright | The United States Government 2014 |
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