Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches

Overview of attention for article published in The AAPS Journal, April 2016

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如果您喜欢药智网推送的这篇文章欢迎点赞和转发哦~ 关于辅料、体内BE研究、溶出度研究和讨论部分的内容编者语： 2016年5月19日CFDA正式发布了【2016】87号《人体生物等效性试验豁免指导原则》，为一致性评价中口服固体常释制剂的BE豁免提供了指导原…

Type: Brief Communication The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain…

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