Scientific decision process and regulation requirements based on the current guidelines of data extrapolation from adult to pediatric population

doi:10.12092/j.issn.1009-2501.2019.01.009

Abstract

Abstract:

AIM: To provide a general overview of the regulatory guidelines on the extrapolation from adult and other data to pediatric population, and to provide some practical advices for following these guidelines. METHODS: Literatures about the topic of "data extrapolation/and pediatric" from website of CFDA, EMA, USFDA, ICH and databases such as Wanfang,CNKI and Pubmed were searched, then the current guidelines on this topic were analyzed and compared, and the strategy for this topic was discussed. RESULTS: The current guidelines of EMA, U.S.FDA and ICH maintained consistent in critical principles. But the difference still required further improvement. The current data extrapolation guidelines laced maneuverability, and the description for some critical concepts and algorithm was not clear. CONCLUSION: Extrapolating efficacy from adult data or other data to the pediatric population can streamline pediatric drug development and help to increase the number of approvals drug for pediatric use, and the ICH E11(R1) that may replace the current guidelines will provide a better way for the pharmaceutical manufacturers to develop drug for pediatric use.

Key words: data extrapolation, off-label, pediatric drug, modeling and simulation

CLC Number:

ZHANG Huimin, LIU Aiming, ZHU Wenfeng, YU Lingzhi, CHEN Fangliang. Scientific decision process and regulation requirements based on the current guidelines of data extrapolation from adult to pediatric population[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(1): 49-56.

References

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