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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Detalles Bibliográficos
Autores principales: Scheerans, Christian, Heinig, Roland, Mueck, Wolfgang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2015
Materias:
Original Papers
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4405076/
https://www.ncbi.nlm.nih.gov/pubmed/25327367
http://dx.doi.org/10.1002/bdd.1923

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4405076/
https://www.ncbi.nlm.nih.gov/pubmed/25327367
http://dx.doi.org/10.1002/bdd.1923

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