A brief review of Phase 1 and Clinical Pharmacology statistics in clinical drug development.
Following a brief description of historical Phase 1 research, Clinical Pharmacology studies, and the role of statistics in this setting, Phase 1 study design and statistical analysis are reviewed. A description of design and analysis for Clinical Pharmacology studies is also provided, and the role of statistics in this area of drug development in the future is discussed. While challenging, this area of statistics in drug development is likely to have an active and engaging future.
Patterson
Scott D
SD
GlaxoSmithKline Pharmaceuticals, Philadelphia, PA, USA. scott.d.patterson@gsk.com
Jones
Byron
B
D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D015195:Drug Design; D006801:Humans; D010600:Pharmacology