药物和诊断试剂联合开发的研发和监管策略。
Development and regulatory strategies for drug and diagnostic co-development.
机构信息
Novartis Pharmaceuticals Corp., East Hanover, NJ 07939-1080, USA.
出版信息
Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141.
At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.
在第 5 届 FDA-药品行业协会（DIA）关于“药物开发和监管决策中的药物基因组学”研讨会上，第四专题集中讨论了治疗性药物或生物制品及其伴随诊断产品联合开发的当前思路和问题。基因组和其他生物标志物的鉴定和验证正在成为药物开发策略的重要组成部分，最近的成功案例表明，个性化方法在改变新药的获益-风险范式方面具有强大的力量。
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