European Journal of Biomedical and Pharmaceutical Sciences

ROLE OF PRECLINICAL STUDIES IN CLINICAL RESEARCH

Girija Kumari*, Vikram Singh

ABSTRACT

The process of developing a novel drug is very 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 pre-clinical 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 pre-clinical evaluation eventually lead to a marketed product. Hence, there is a need for optimizing current standard pre-clinical approaches to better mimic the complexity of human disease mechanisms. In order to ensure relevant results applied in clinical contexts, effective development and careful selection of modeling frames for preclinical trials are crucial. The purpose of this research is to study a variation in the time line between in vitro, in vivo and silicone models, and the limits of pre-clinical treatment trials.

Keywords: Drug, Pharmacodynamics, Pharmacokinetics, Toxicology, Clinical trials, Pre-clinical models.