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# CDER Working on Pediatric Extrapolation Framework
- URL: https://www.fdaweb.com/cder-working-on-pediatric-extrapolation-framework/
- Published: 2022-08-18T12:00:00.000Z
- Updated: 2026-09-14T17:56:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152541

CDER researchers are developing a quantitative framework to describe the exposure-response relationship and the difference in exposure-response between populations to support extrapolation of efficacy in drug development programs from adults to pediatric populations. An online [post](https://www.fda.gov/drugs/regulatory-science-action/applying-non-inferiority-paradigm-assess-exposure-response-and-dosing-comparisons-between-pediatric?ref=fdaweb.com) says there are often challenges in pediatric drug development that lead investigators to extrapolate evidence for drug approvals in adults and older pediatric patients to inform aspects of drug review relevant to younger pediatric patients.

The post says a qualitative framework “can provide more objective criteria for assessments of exposure-response similarity, strengthening the scientific evidence available for determining whether drugs approved in adult populations can be assessed as safe and effective for pediatric use.”

It reviews the non-inferiority paradigm to assess exposure-response similarity between pediatric and adult patients.