Designing optimal non-clinical development programs to advance medicinal products
Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxico- kinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria, maximizing the chances of success in subsequent stages of development. Strategies for the non-clinical development of candidate drugs do not follow general regulatory guidelines but are developed on a case-by-case basis according to the specifics of the drug. It is essential to design an optimal non-clinical development program that enables the medicinal product to be taken forward to the next phase in clinical development, or to product registration.