Current Edition

Key Challenges in API Characterisation and its Impacts

The cost of bringing a new drug to the market has soared to over $2 billion. This results from drug development activities that are long, arduous, and costly, with complex modality and a high degree of uncertainty. Tilak Chandrasekaran B.Pharm, MBA, and Lester Taylor Ph.D, conclude that this is partly due to insufficient knowledge regarding the mechanism of disease, process understanding, and keeping up with regulatory pressure to deliver drugs that are safe, efficacious, and of high quality.