Tremaine Larry, Brian William, DelMonte Terrye, Francke Stephan, Groenen Peter, Johnson Keith, Li Lei, Pearson Kimberly, Marshall Jean-Claude
Pfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA.
Sanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA.
Pharmacogenomics. 2015 Dec;16(18):2055-67. doi: 10.2217/pgs.15.141. Epub 2015 Nov 30.
Genetic polymorphisms in metabolizing enzymes and drug transporters have been shown to significantly impact the exposure of drugs having a high dependence on a single mechanism for their absorption, distribution or clearance, such that genotyping can lead to actionable steps in disease treatment. Recently, global regulatory agencies have provided guidance for assessment of pharmacogenomics during early stages of drug development, both in the form of formal guidance and perspectives published in scientific journals. The Industry Pharmacogenomics Working Group (I-PWG), conducted a survey among member companies to assess the practices relating to absorption, distribution, metabolism, excretion pharmacogenomics) during early stages of clinical development, to assess the impact of the recent Regulatory Guidance issued by the US FDA and EMA on Industry practices.
代谢酶和药物转运体中的基因多态性已被证明会显著影响高度依赖单一吸收、分布或清除机制的药物的暴露情况，因此基因分型可在疾病治疗中带来可采取行动的步骤。最近，全球监管机构以正式指南和发表在科学期刊上的观点等形式，为药物开发早期阶段的药物基因组学评估提供了指导。行业药物基因组学工作组（I-PWG）对成员公司进行了一项调查，以评估临床开发早期阶段与吸收、分布、代谢、排泄药物基因组学相关的实践，评估美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）最近发布的监管指南对行业实践的影响。
