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• W2100070996 abstract "Dr. Robert T. O'Neill has been on the forefront of regulatory statistical science since he came to the Food and Drug Administration in 1970. He worked to shape the statistical framework for the drug approval process for all new drugs marketed in the United States following passage of the 1962 Kefauver-Harris Amendments. This article will focus on Dr. O'Neill's responses to challenges in the field of drug development and evaluation and Dr. O'Neill's broad and influential role in the conceptualization and evolution of a systematic, statistically based approach to answering the question “Does this drug really work?” Statisticians working in pharmaceutical science have learned from his pioneering work and sound instincts in a regulatory environment but have also profited from his willingness to communicate through talks, travel, and publications over the years. We will describe some of the statistical principles he articulated so well and consider the role of clinical trial related statistical methodology ove..." @default.
• W2100070996 created "2016-06-24" @default.
• W2100070996 creator A5014185274 @default.
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• W2100070996 date "2013-08-01" @default.
• W2100070996 modified "2023-09-26" @default.
• W2100070996 title "Contributions of Robert T. O’Neill to the Evolution of Regulatory Statistical Science" @default.
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• W2100070996 doi "https://doi.org/10.1080/19466315.2013.818817" @default.
• W2100070996 hasPublicationYear "2013" @default.
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