Lowes S, Hucker R, Jemal M, Marini J C, Rezende V M, Shoup R, Singhal P, Timmerman P, Yoneyama T, Weng N, Zimmer D
Bioanalytical and ADME Labs, Quintiles, 19 Brown Road, Ithaca, New York, 14850, USA,
AAPS J. 2015 Jan;17(1):17-23. doi: 10.1208/s12248-014-9656-x. Epub 2014 Oct 23.
The A2 harmonization team, a part of the Global Bioanalysis Consortium (GBC), focused on defining possible tiers of chromatographic-based bioanalytical method performance. The need for developing bioanalytical methods suitable for the intended use is not a new proposal and is already referenced in regulatory guidance language. However, the practical implementation of approaches that differ from the well-established full validation requirements has proven challenging. Advances in technologies, the need to progress drug development more efficiently, and emerging new drug compound classes support the use of categorized tiers of bioanalytical methods. This paper incorporated the input from an international team of experienced bioanalysts to surmise the advantages and the challenges of tiered approaches and to provide recommendations on paths forward.
A2协调团队作为全球生物分析联盟（GBC）的一部分，专注于定义基于色谱的生物分析方法性能的可能层级。开发适用于预期用途的生物分析方法并非新提议，监管指南语言中已有相关提及。然而，与既定的全面验证要求不同的方法在实际实施中已证明具有挑战性。技术进步、更高效推进药物开发的需求以及新兴的新型药物化合物类别支持使用分类层级的生物分析方法。本文纳入了一个由经验丰富的生物分析师组成的国际团队的意见，以推测分层方法的优势和挑战，并就未来的发展路径提供建议。
