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# Pediatric Drug Extrapolation in U.S. Analyzed
- URL: https://www.fdaweb.com/pediatric-drug-extrapolation-in-u-s-analyzed/
- Published: 2023-02-15T12:00:00.000Z
- Updated: 2026-09-14T18:16:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153788

Researchers from several organizations and institutions say the use of extrapolation from adult to pediatric drugs between 1/1/2015 and 7/31/2021 increased the rates of new and expanded indications in the period. Writing in the *Journal of Biopharmaceutical Statistics* (purchase required), the researchers [say](https://www.tandfonline.com/doi/full/10.1080/10543406.2023.2170407?ref=fdaweb.com) that within the time window they studied, among the 265 drugs and biological products with pediatric labeling changes, 169 (63.8%) were identified where extrapolation was used. That included 64 (24.2%) labeling changes where full extrapolation was used, and 105 (39.6%) labeling changes where partial extrapolation was used.

The major disease areas in which extrapolation was used included neuroscience and infectious disease.