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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2019
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| Materias: | |
| 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 |