Science-led regulatory strategies in nonclinical development of new medicines

Abstract The development of a pharmaceutical is a stepwise process involving an evaluation of both animal and human efficacy and safety information. Regulations around drug development exist to protect people and the environment from harm and should create a level playing field for business, allowing well-run companies to thrive. However, adherence to good science should guide decisions rather than rigorously following guidelines, and there is almost always more than one way to get to the ultimate goal.