Medical Writing Preclinical Studies Preclinical research in drug development

Volume 26, Issue 4 - Preclinical Studies

Preclinical research in drug development

Abstract

The process of developing a novel drug is time consuming and costly. To increase the chances of successfully completing a clinical trial leading to the approval of a new drug, the choice of appropriate preclinical models is of utmost importance. Identifying a safe, potent, and efficacious drug requires thorough preclinical testing, which evaluates aspects of pharmacodynamics, pharmacokinetics, and toxicology in in vitro and in vivo settings.  Nevertheless, merely a small fraction of investigational new drugs tested in clinical trials after passing preclinical evaluation eventually lead to a marketed product. Hence, there is a need for optimising current standard preclinical approaches to better mimic the complexity of human disease mechanisms.
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