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Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval

Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug application. In...

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Detalles Bibliográficos
Autores principales:	Uzu, Shinobu, Sekine, Shohko, Asano, Junichi, Ikuma, Mutsuhiro
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604230/ https://www.ncbi.nlm.nih.gov/pubmed/34121342 http://dx.doi.org/10.1111/cts.13098

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