Paediatric developmental safety and the ICH E11A extrapolation of safety
Authors
- Susan M. Abdel‐Rahman (ORCID: https://orcid.org/0000-0002-5815-2029)
- Gelareh A. Abulwerdi (ORCID: https://orcid.org/0000-0002-1036-6378)
- Sherbet Samuels (ORCID: https://orcid.org/0009-0001-1569-6157)
- Rebecca Racz (ORCID: https://orcid.org/0000-0002-5487-5692)
- Lynne P. Yao (ORCID: https://orcid.org/0009-0004-7611-217X)
- Dionna J. Green
- Gilbert J. Burckart (ORCID: https://orcid.org/0000-0003-2005-9301)
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2025-11-29
- DOI
- https://doi.org/10.1002/bcp.70393
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00