Transl Clin Pharmacol.
2021 Jun;29(2):73-77. 10.12793/tcp.2021.29.e11.
Adequacy of safety data for regulatory approval of pediatric indication through extrapolation algorithm
- Park MS
1,2,3
- Affiliations
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- 1Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea
- 2Department of Pediatrics, Yonsei University College of Medicine, Seoul 03722, Korea
- 3Department of Pharmaceutical Medicine and Regulatory Science, Graduate Program, Yonsei University College of Medicine, Seoul 03722, Korea
- KMID: 2525611
- DOI: http://doi.org/10.12793/tcp.2021.29.e11
Abstract
- no abstract available.
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