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

Research output: Contribution to journalArticlepeer-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 languageAmerican English
JournalJournal of Biopharmaceutical Statistics
Volume11
DOIs
StatePublished - 2001

Keywords

  • FDA
  • Pharmaceutical industry
  • Regulation

DC Disciplines

  • Public Health
  • Biostatistics

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