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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...
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| 出版年: | Clin Pharmacol Ther |
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| 主要な著者: | , , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
John Wiley and Sons Inc.
2019
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| 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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