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USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products" which is open for comments.

Sponsors and applicants of investigational new drug applications (INDs), biologics license applications (BLAs), and supplements to such applications planning to conduct clinical trials in pediatric populations may find this guidance useful.


Clinical pharmacology studies in the pediatric population should be conducted in individuals with the disease which the drug is intended to treat, or in rare instances, in those who are at risk of this disease.


The CDER generally divides the pediatric population into the following groups:

• Neonates: Birth up to 1 month

• Infants: 1 month up to 2 years

• Children: 2 years up to 12 years

• Adolescents: 12 years up to younger than 17 years


The purpose of this guidance is to address general clinical pharmacology considerations for conducting studies to adequately characterize the dosing and safety information for drugs in pediatric populations so that well-designed trials can be conducted to determine their effectiveness.


This guidance is designed to help identify appropriate dosages for pediatric populations based on clinical pharmacology data (e.g., exposure-response, pharmacokinetics, and pharmacodynamics).


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