Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of necessary clinical studies, maximizing available clinical data using model-informed drug development (MIDD) approaches, and expert communication of integrated information.
In the webinar, Certara’s APAC consulting team will discuss common issues that have impacted or delayed approvability in FDA applications. In addition, commonly asked questions that arise for global programs with a focus on Japan, China, and Korea will be presented.