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Physiologically Based Pharmacokinetics Is Impacting Drug Development and Regulatory Decision Making

It is no coincidence that the reports of two meetings, one organized by the US Food and Drug Administration (FDA), in March 2014, and the other by the UK Medicines and Healthcare Products Regulatory (MHRA), in collaboration with ABPI (the Association of British Pharmaceutical Industry), in June 2014...

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Detalles Bibliográficos
Autores principales: Rowland, M, Lesko, LJ, Rostami-Hodjegan, A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4505824/
https://www.ncbi.nlm.nih.gov/pubmed/26225258
http://dx.doi.org/10.1002/psp4.52