Making Decisions about Safety in Clinical Trials — The Case for Inferential Statistics

Autor: Enas, Gregory G.
Zdroj: Drug Information Journal; July 1991, Vol. 25 Issue: 3 p439-446, 8p
Abstrakt: While not required for every adverse event, inferential statistical methods can be used both formally and informally to help characterize the safety profile of a new drug and help guide the resulting inferences to the broader population. Examples of probability statements will be shown when used both formally and informally. The particular setting or phase of clinical drug development dictates to some degree whether description with or without formal inference is appropriate.
Databáze: Supplemental Index