General Considerations for Pediatric Formulation Development: Setting Target Product Profiles

Developing new drugs for children and the corresponding age-appropriate dosage forms and formulations are complex tasks. In this chapter, we describe the use of a simple but powerful methodology: developing a Pediatric Quality Target Product Profile (ped QTPP) to generate focus and clarity for the product to be developed. In this context, “Quality” is a synonym for “Chemistry, Manufacturing, and Controls” (CMC). A proposal for structure and content of the ped QTPP is provided, as well as suggestions on how this “living document” can be used by the formulation scientists and project teams to guide compound development strategies and plans.