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Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing authorization to the European Medicines Agency for generi...
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| 出版年: | Clin Transl Sci |
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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/PMC6742938/ https://ncbi.nlm.nih.gov/pubmed/31046182 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12642 |
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