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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Real‐world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning that underlies study design decisions is critical. Building on existi...

詳細記述

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書誌詳細
出版年:Clin Pharmacol Ther
主要な著者: Gatto, Nicolle M., Reynolds, Robert F., Campbell, Ulka B.
フォーマット: Artigo
言語:Inglês
出版事項: John Wiley and Sons Inc. 2019
主題:
オンライン・アクセス:https://ncbi.nlm.nih.gov/pmc/articles/PMC6771466/
https://ncbi.nlm.nih.gov/pubmed/31025311
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1480
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