In vitro ADME Screening Instead of in vivo Studies in Preclinical Safety

Advances of in silico, ex vivo, and in vivo testing of the preclinical safety of newly developed pharmaceutical drugs before being administered in humans, is a fundamental step in drug manufacturing. Nowadays, animal testing plays an essential role in the evaluation of drug safety before progression into clinical trials. In recent years, several ex vivo tests have been developed and used in new screening processes to evaluate the toxicity of potential therapeutic molecules. This has led to a great replacement or reduction of in vivo assays. Accordingly, many pharmaceutical industries have a high demand for in vitro assays, and they are inclined to support the primary knowledge of developing novel drugs with adherence to the strategy of 3Rs (reduction, refinement, and replacement). It asserts that in vivo tests should be reduced, refined, and replaced by other preclinical techniques. Recently, using combinational chemistry and highthroughput screening (HTS) has increased the required information on a wide range of candidate molecules in terms of their absorption, distribution, metabolism, excretion, and toxicity (ADMET); which has resulted in a lot of ex vivo ADMET assessments. In this review, we have discussed the methods and tests which have the potential to replace the animal assays; and have addressed their advantages and limitations

: In-vitro; Pharmaceutical industry; 3R; ADMET