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Assessment of Drugs Approved by Public Knowledge‐Based Applications (Kouchi‐shinsei) During the Last Two Decades in Japan

Public knowledge‐based application (“Kouchi‐shinsei” in Japanese) is unique to Japan, implemented to eliminate the off‐label use of unapproved indications, dosages, and administrations because of drug lag. The guidance for public knowledge‐based application was issued in 1999. This study comprehensi...

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Detalles Bibliográficos
Autores principales: Maeda, Hideki, Fukuda, Yuka, Uchida, Marika
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518418/
https://www.ncbi.nlm.nih.gov/pubmed/34110632
http://dx.doi.org/10.1002/cpt.2332