A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan

INTRODUCTION: In Japan, the PMDA conducted inspections based on GCP in the review process of the submission of NDAs or sNDAs. In this descriptive study, we examined in detail the contents of exclusion data from submitted clinical data package subjects in the results of GCP inspections in Japan for N...

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Detalles Bibliográficos
Autores principales: Asada, Ryuta, Yoshimura, Kenichi, Hattori, Kayo, Nonaka, Yujiro, Kasai, Hiroi, Shimizu, Shinobu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6682372/
https://www.ncbi.nlm.nih.gov/pubmed/31406948
http://dx.doi.org/10.1016/j.conctc.2019.100416

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6682372/
https://www.ncbi.nlm.nih.gov/pubmed/31406948
http://dx.doi.org/10.1016/j.conctc.2019.100416

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