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  • Title: Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future.
    Author: Segreti AC, Leung HM, Koch GG, Davis RL, Mohberg NR, Peace KE.
    Journal: J Biopharm Stat; 2001 Nov; 11(4):347-72. PubMed ID: 12018784.
    Abstract:
    The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change.
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