Pharmaceutical Risk Assessment and Predictive Enrichment to Maximize Benefit and Minimize Risk: Issues in Product Life Cycle Evaluation
作者： Robert T. O’Neill
DOI: 10.1007/978-1-4614-8981-8_17
关键词:
摘要: Use of pharmaceutical products provides many benefits to patients but there is also a need assess the risks associated with afforded by these exposures. This paper focuses on FDA’s response variety safety issues in arena that have received broad public attention last few years and extremely important role statistics playing will play shaping nation's future systematic approach addressing facets medical product quantitative risk assessment management. The emphasis be life cycle evaluation which includes pre-market post-market or post-approval period as they are used populations all ages ethnicities, alone combination, for short very long periods time. Additionally, advent genomic revolution, interest personalized medicine search predictive biomarkers aid patient selection treatment strategies has opened up methodological challenges new prediction strategies. Clinical trial study designs evaluate targeted therapy enrich major focus this area. touches areas from perspective development evaluation.
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