Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
Abstract 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 applica...
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| Autores principales: | , , , |
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| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Wiley
2021
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| Materias: | |
| Acceso en línea: | https://doaj.org/article/4f110dba9e164384af91d02ec52ee583 |
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