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Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan
Recently, post‐marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems. Pharmacists are expected to play an active role in ensuring the safety of drugs post‐approval. Utilizing risk management pla...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10293701/ https://www.ncbi.nlm.nih.gov/pubmed/37365794 http://dx.doi.org/10.1002/prp2.1110 |