• Kenneth C. Cassidy Ph.D.
  • Anette Mullertz Ph.D.
  • Ben X. Nguyen M.S.

Proposal Description:

Pediatric drug development is a growing focus area in the pharmaceutical industry. Prior to submitting a new drug application or a line extension application for a new medicine, the Food and Drug Administration requires a Pediatric Study Plan, and the European Medicines Agency requires a Pediatric Investigation Plan. Both are intended to encourage development of new drugs suitable for the pediatric patient population. But why is this necessary and what exactly is required, where and when? Optimizing dose selection in pediatric drug development is challenging and requires both pharmacokinetic and pharmacodynamic (PK/PD) inputs. PK/PD approaches and considerations in this pediatric space will be discussed.