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General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products September 2022


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1275

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Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance assists sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), biologics license applications (BLAs) under section 351(a) of the Public Health Service Act (PHS Act), and supplements to such applications who are planning to conduct clinical studies in pediatric populations. In addition, this guidance assists clinical investigators in the design and planning of, and Institutional Review Boards (IRBs) in the assessment of, clinical studies in pediatric populations.

Effectiveness, safety, or dose-finding studies in pediatric populations involve gathering clinical pharmacology information, such as information regarding a product’s pharmacokinetics and pharmacodynamics, to inform dose selection and individualization. This guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs in pediatric populations can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness. This guidance focuses on the clinical pharmacology information (e.g., exposure-response, pharmacokinetics, and pharmacodynamics) that supports findings of effectiveness and safety and helps identify appropriate doses in pediatric populations. This guidance also describes how quantitative approaches (i.e., pharmacometrics) can use disease and exposure-response knowledge from relevant prior clinical studies to help design and evaluate future pediatric studies.

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