Srinivas Nuggehally R, Mullangi Ramesh
Dr Reddy's Institute of Life Sciences, Gachibowli, Hyderabad, Telangana, India.
Drug Metabolism & Pharmacokinetics, Jubilant Biosys, Yeshwanthpur, Bangalore, Karnataka, India.
Biomark Med. 2015;9(9):877-86. doi: 10.2217/bmm.15.65. Epub 2015 Sep 2.
Bioanalysis is an important aspect of drug discovery process regardless of the chosen therapeutic area. There is a general misconception that bioanalysis is seldom important during the drug discovery process because there is no scrutiny of the data from a regulatory perspective. However, bioanalytical data gathered during the discovery stage enable several key decision(s) inclusive of termination of the program and/or creating adequate differentiation from the lead competitive molecules. The review covers various stage gate screens and experimental designs where bioanalytical data are extensively used for making an informed decision during the process of drug discovery.
无论选择何种治疗领域，生物分析都是药物发现过程中的一个重要方面。人们普遍存在一种误解，认为在药物发现过程中生物分析很少重要，因为没有从监管角度对数据进行审查。然而，在发现阶段收集的生物分析数据能够做出几个关键决策，包括终止该项目和/或与领先的竞争分子形成足够的差异化。本综述涵盖了各个阶段关卡筛选和实验设计，在药物发现过程中，生物分析数据被广泛用于做出明智的决策。
