Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

Drug discovery process is an iterative process and prioritizing compounds is a natural process with ultimate goal of selecting a lead compound as a preclinical development. Typically scientists prioritize compounds based on potency, selectivity, DMPK profile and in vivo efficacy; while toxicity studies were performed later part of the process or even after selecting the pre-clinical candidate. Several reports suggest that more than half of pre-clinical candidate and about one quarter of drug candidates entering clinical development fail due to non-clinical toxicology or clinical safety issues. The late stage failure account for a large proportion of the cost of pharmaceutical R & D, recently estimated to be $2 B per marketed drug. Recently, the toxicity profiling studies have been shifted to early part of the discovery process and many tools including surrogate in vitro assays and in silico prediction software. FDA is also developing their guidelines to replace/reduce animal studies with other tools for the humane consideration. We will present recent advances in predicting toxicity profile of drug candidates and case studies to show the benefits of incorporating toxicity profile early in the drug discovery process.

Biography

Email: JPadia@som.umaryland.edu