Biopharmaceutical statistics in a pharmaceutical regulated environment: Past, present, and future

Karl E. Peace; Anthony C. Segreti; Hoi M. Leung; Gary G. Koch; Robert L. Davis; Noel R. Mohberg

doi:10.1081/bip-120006096

Biopharmaceutical statistics in a pharmaceutical regulated environment: Past, present, and future

Karl E. Peace, Anthony C. Segreti, Hoi M. Leung, Gary G. Koch, Robert L. Davis, Noel R. Mohberg

Biostatistics, Epidemiology & Environmental Health Sciences

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

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.

Original language	English
Pages (from-to)	347-372
Number of pages	26
Journal	Journal of Biopharmaceutical Statistics
Volume	11
Issue number	4
DOIs	https://doi.org/10.1081/bip-120006096
State	Published - Jan 1 2002

Scopus Subject Areas

Statistics and Probability
Pharmacology
Pharmacology (medical)

Keywords

FDA
Pharmaceutical industry
Regulation

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10.1081/bip-120006096License: CC BY

Cite this

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AU - Mohberg, Noel R.

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Biopharmaceutical statistics in a pharmaceutical regulated environment: Past, present, and future

Abstract

Scopus Subject Areas

Keywords

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