The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials

Gerald L. Klein, Roger Morgan
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Abstract

Conducting clinical trials is the process that biopharmaceutical companies must use to demonstrate that their product is safe, well-tolerated, and efficacious to obtain marketing approval from the Food and Drug Administration (FDA)
无偏见的安全审查委员会在 I 期临床试验中的重要性
开展临床试验是生物制药公司为获得美国食品药品管理局 (FDA) 批准上市而必须证明其产品安全、耐受性好、疗效显著的过程。
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