Do Regulatory Bioequivalence Requirements Adequately Reflect the Therapeutic Equivalence of Modified-Release Drug Products?
Purpose. To demonstrate that current regulatory requirements for bioequivalence (BE) do not always reflect therapeutic equivalence. To investigate the potential usefulness of an additional metric, the partial AUC. Methods. Pharmacokinetic information was reviewed and evaluated on the pharmacokinet...
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| Principais autores: | , |
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| Format: | Artigo |
| Sprog: | Inglês |
| Udgivet: |
Frontiers Media S.A.
2010-05-01
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| Serier: | Journal of Pharmacy & Pharmaceutical Sciences |
| Online adgang: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/8246 |
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