Ethical perspectives on pharmacogenomic profiling in the drug development process.
作者： Amalia M. Issa
DOI: 10.1038/NRD771
关键词: Drug response 、 Engineering ethics 、 Drug development 、 Research design 、 Profiling (information science) 、 Pharmacogenomics 、 Biotechnology 、 Medicine
摘要: Pharmacogenomics, which is a field that encompasses the study of genetic polymorphisms underlie individual differences in drug response, rapidly advancing. The potential for widespread use pharmacogenomics development process merits an examination its fundamental impact on clinical-trial design and practice. This article provides critical analysis some issues pertain to process. In particular, four areas will be discussed: design; subject stratification; new social risks; economic concerns. Recommendations are offered addressing discussed anticipating regulatory needs pharmacogenomics-based trials.
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