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Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines
The European Medicines Agency's (EMA) product‐specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As...
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| Опубликовано в: : | Clin Pharmacol Ther |
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| Главные авторы: | , , , , |
| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
John Wiley and Sons Inc.
2018
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| Предметы: | |
| Online-ссылка: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6175295/ https://ncbi.nlm.nih.gov/pubmed/29319156 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.957 |
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