Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.

Alexei C Ionan, Jennifer Clark, James Travis, Anup Amatya, John Scott, James P Smith, Somesh Chattopadhyay, Mary Jo Salerno, Mark Rothmann

Therapeutic innovation & regulatory science 2023 May

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The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.S. public health by helping to ensure that safe and effective drugs and biological products are available in the United States for those who need them. The null hypothesis significance testing approach, along with other considerations, is typically used to demonstrate the effectiveness of a drug or biological product. The Bayesian framework presents an alternative approach to demonstrate the effectiveness of a treatment. This article discusses the Bayesian framework for drug and biological product development, highlights key settings in which Bayesian approaches may be appropriate, and provides recent examples of the use of Bayesian approaches within CDER and CBER. © 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

Citation

Alexei C Ionan, Jennifer Clark, James Travis, Anup Amatya, John Scott, James P Smith, Somesh Chattopadhyay, Mary Jo Salerno, Mark Rothmann. Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER. Therapeutic innovation & regulatory science. 2023 May;57(3):436-444