Drug Development Process and Regulatory Science

Abstract

The pursuit of antimicrobial drug development has been met with reluctance by many large pharmaceutical companies. In part, this has been due to the enormous resources required to meet regulatory standards, the risk of failure, and the current perception of regulatory uncertainty. This comes at a time when rates of antimicrobial resistance are on the rise across the globe, and there is a critical need for antimicrobial therapy. In this review, emphasis has been placed on the regulatory incentives to enhance antimicrobial drug development, and the value of pharmacokinetics-pharmacodynamics (PK-PD) principles from early development of an antimicrobial agent through late stage and post-approval/life cycle management strategies in accordance with recent guidelines. This demonstrates the potential to not only streamline the development process, driving down costs and time, but also improve the likelihood of regulatory success, making antibiotic drug development more viable and these needed agents available to the therapeutic armamentarium.