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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 no: | Biopharm Drug Dispos |
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| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Blackwell Publishing Ltd
2015
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| Assuntos: | |
| Acesso em linha: | 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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