Paediatric developmental safety and the ICH E11A extrapolation of safety.
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| Title: | Paediatric developmental safety and the ICH E11A extrapolation of safety. |
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| Authors: | Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Abdel-Rahman SM; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Abulwerdi G; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Racz R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Samuels S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Green DJ; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA., Yao LP; Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. |
| Source: | British journal of clinical pharmacology [Br J Clin Pharmacol] 2025 Nov 29. Date of Electronic Publication: 2025 Nov 29. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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