Preclinical Development

Synthesis of new chemical entities is done as per research policy decision which is based on:

(i) Random synthesis
(ii) Structure activity relationship (SAR)
(iii) Biochemical and pharmacological insight and
(iv) Chance finding.

The aim of the preclinical development phase for a potential new medicine is to explore the drug’s efficacy and safety before it is administrated to patients. In this preclinical phase, varying drug doses are tested on animals and/or in vitro systems.
If active compounds are found, then studies on animals are done which include
pharmacodynamics, pharmacokinetics, toxicology and special toxicological tudies
(mutagenicity and carcinogenicity) have to be done. In this study single dose is used for acute toxicity and repeated doses for sub chronic and chronic toxicity studies. Most of the preclinical tests have to be conducted in accordance with the standards prescribed.