Report from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation

On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis.(1) Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.

Detalles Bibliográficos
Autor principal: Zhao, P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321806/
https://www.ncbi.nlm.nih.gov/pubmed/28035755
http://dx.doi.org/10.1002/psp4.12166
Descripción
Sumario:On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis.(1) Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.

Ejemplares similares