Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms
作者: Andre HermansAndreas M. AbendFilippos KesisoglouTalia FlanaganMichael J. CohenDorys A. DiazY. MaoLimin ZhangGregory K. WebsterYiqing LinDavid A. HahnCarrie A. CoutantHaiyan Grady
作者单位: 1Merck & Co., Inc.
2AstraZeneca R&D
3Pfizer Inc.
4Bristol-Myers Squibb Company
5AbbVie Inc.
6Biogen Inc.
7Genentech, Inc.
8Eli Lilly & Co., Lilly Corporate Center
9Takeda Development Center Americas, Inc.
刊名: The AAPS Journal, 2017, Vol.19 (6), pp.1537-1549
来源数据库: Springer Journal
DOI: 10.1208/s12248-017-0117-1
关键词: BCSBiowaiversClinically relevant dissolution specificationsPBPK modelingSUPAC
英文摘要: This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of...
原始语种摘要: This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of...
全文获取路径: Springer  (合作)
分享到:
来源刊物:
影响因子:4.386 (2012)

×
关键词翻译
关键词翻译
  • specifications 技术条件
  • Release 免除释放机构
  • dissolution 溶解
  • additional 追加的
  • unnecessarily 不必要地
  • manuscript 原稿
  • light 
  • provided 只要
  • toward 
  • understanding 理解