| 期刊全称 | Bioequivalence Requirements in Various Global Jurisdictions | | 影响因子2023 | Isadore Kanfer | | 视频video | | | 发行地址 | Combines BE (bioequivalence) standards from across the world into a single reference source.Provides essential information for market approval of generic products.Attempts to harmonize country specifi | | 学科分类 | AAPS Advances in the Pharmaceutical Sciences Series | | 图书封面 |  | | 影响因子 | .Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of .Bioequivalence Requirements. in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the. USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market appro | | Pindex | Book 2017 |
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发表于 2025-3-21 16:45:28
