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...

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Salvato in:
Dettagli Bibliografici
Pubblicato in:Clin Pharmacol Ther
Autori principali: Asano, Kunihito, Aoi, Yoko, Kamada, Shuji, Uyama, Yoshiaki, Tohkin, Masahiro
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2020
Soggetti:
Research
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC8246727/
https://ncbi.nlm.nih.gov/pubmed/33245786
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.2121
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