| 摘要: |
| 生物药剂学分类系统（Biopharmaceutics classification system, BCS）是根据药物的溶解性与渗透性进行分类的一种科学框架，已被欧洲药品管理局（EMEA）、美国食品药品管理局（FDA）、世界卫生组织（WHO）等认可并用作仿制药物生物等效性豁免的判断依据。随着人药BCS的发展，一些研究人员尝试将BCS引入到兽药领域，以指导兽用仿制药的开发和管理。因此本文针对BCS分类标准和概念、BCS在人药研发和管理中的应用、兽药BCS发展现状及其面临的挑战进行了总结，以期为兽药BCS分类系统的发展提供有益的借鉴和指导，为新兽药的开发和老药的改造提供理论基础。 |
| 关键词: 生物药剂学分类系统(BCS) 分类标准 研究现状 挑战 策略 |
| DOI： |
| 投稿时间：2017-12-15修订日期：2018-06-01 |
| 基金项目:国家重点研发计划专项“畜禽重要病原耐药性检测与控制技术研究”（2016YFD0501309） |
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| Research Progress on Veterinary Drug Biopharmaceutics Classification System (BCS) |
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| (National Reference Laboratory of Veterinary Drug Residues(HZAU) Huazhong Agricultural University) |
| Abstract: |
| Biopharmaceutics Classification System (BCS) based on the solubility and permeability of drug is a scientific frame. It has been applied to judge the bioequivalence exemption of generic drug by European Medicines Agency (EMEA), Food and Drug Administration (FDA) and the World Health Organization (WHO), With the development of BCS, some researchers attempt to introduce it into the field of veterinary drug to guide the development and management of generics. This review mainly summarizes the standards and concepts of BCS classification, the application of BCS in the research and administration of human drug, the BCS development status and challenges of veterinary drug BCS, and then providing some useful references and strategies for the development of veterinary drug BCS. |
| Key words: Biopharmaceutical Classification System (BCS) Classification criteria Current researches Challenges Strategies |
