On December 08, 2014, US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on how to conduct pediatrics studies for new drugs and biologics.
This draft guidance details particularly the clinical pharmacology information (e.g. exposure-response, pharmacokinetics, and pharmacodynamics) needed to support findings of effectiveness and safety while helpings identify appropriate doses in pediatric populations. In addition, the guidance recommends the phamacometrics approach from relevant prior clinical studies to design and evaluate future pediatrics studies.
This draft guidance does not recommend on:
1) Standards for approval of drugs and biological products in the pediatric population,
2) Criteria to allow a determination that the course of a disease and the effects of a drug or a biologic are the same in adults and pediatric populations, or
3) Clinical pharmacology studies for vaccine therapy, blood products, or other products not regulated by the Center for Drug Evaluation and Research