E11A Pediatric Extrapolation: Guidance for Industry¶
International Council for Harmonisation, & U.S. Food and Drug Administration. (2024). E11A Pediatric Extrapolation: Guidance for Industry: Guidance for Industry.
Cited by¶
1 citation across 1 artifact.
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Primes¶
- Extrapolation Beyond Sampled Regime
- Pharmacological dosing: adult-trial cohorts extrapolated to paediatric, geriatric, pregnant, or polypharmacy populations, with the trial's efficacy and safety indicators reported at the same precision in groups never in the trial.
This sourceSets the conditions under which adult clinical-trial efficacy/safety may be extrapolated to pediatric and other excluded populations — requiring similarity of disease, response, and exposure-response — establishing that extrapolation beyond the trial cohort is not automatic and must be justified.
- Pharmacological dosing: adult-trial cohorts extrapolated to paediatric, geriatric, pregnant, or polypharmacy populations, with the trial's efficacy and safety indicators reported at the same precision in groups never in the trial.
Verification¶
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Registry ID ref:5fd8cd66d07f · see in the full table