通过外推算法为儿科适应症的监管批准提供充足的安全数据。

IF 1.1 Q4 PHARMACOLOGY & PHARMACY Translational and Clinical Pharmacology Pub Date : 2021-06-01 Epub Date: 2021-06-21 DOI:10.12793/tcp.2021.29.e11

Min Soo Park

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Adequacy of safety data for regulatory approval of pediatric indication through extrapolation algorithm.

https://tcpharm.org This commentary deals with the realistic difficulty arising from the haziness as to what safety data should mean, especially for regulatory authorities to feel confident that approval of new drug indications for pediatric populations could be endowed, and when you were guided that complete extrapolation of adult efficacy data would be possible with an additional pharmacokinetic (PK) study, but safety data cannot be extrapolated.

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来源期刊

Translational and Clinical Pharmacology Medicine-Pharmacology (medical)

CiteScore

1.60

自引率

11.10%

发文量

期刊介绍： Translational and Clinical Pharmacology (Transl Clin Pharmacol, TCP) is the official journal of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT). TCP is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of translational and clinical pharmacology. The categories for publication include pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics, pharmacoepidemiology, pharmacovigilence, and human pharmacology. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.