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Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms
Recently, the European Medicines Agency (EMA) published the new draft guideline on the pharmacokinetic and clinical evaluation of modified release (MR) formulations. The draft guideline contains the new requirement of performing multiple dose (MD) bioequivalence studies, in the case when the MR form...
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| Publicado en: | Biopharm Drug Dispos |
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| Autores principales: | , , |
| Formato: | Artigo |
| Lenguaje: | Inglês |
| Publicado: |
Blackwell Publishing Ltd
2015
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| Materias: | |
| Acceso en línea: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4405076/ https://ncbi.nlm.nih.gov/pubmed/25327367 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/bdd.1923 |
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