Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan

We identified the major points that are described in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline but have not been considered in the past multiregional clinical trials (MRCTs) used for drug approval in Japan to elucidate...

Descripción completa

Detalles Bibliográficos
Autores principales: Asano, Kunihito, Aoi, Yoko, Kamada, Shuji, Uyama, Yoshiaki, Tohkin, Masahiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246727/
https://www.ncbi.nlm.nih.gov/pubmed/33245786
http://dx.doi.org/10.1002/cpt.2121

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246727/
https://www.ncbi.nlm.nih.gov/pubmed/33245786
http://dx.doi.org/10.1002/cpt.2121

Ejemplares similares