Use of disease models in the development and evaluation of therapeutic agents.

Abstract

A key part of the regulatory review of new therapeutic agents depends on a clear demonstration of their efficacy. There can be difficulties when the evaluations of efficacy depend only on in vitro studies, such as minimum inhibitory concentrations (MICs), and clinical field trials. The MIC data often correlate poorly with in vivo results, and field trials can suffer from the unpredictability of disease outbreaks and from differences in the severity of outbreaks at different sites. This paper discusses the use of experimentally induced diseases as a means of bridging the gap between the in vitro data and the results of field trials.