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Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval

The basic components of regulatory and supporting policies for orphan drug development appear similar between the United States and Japan, but drugs designated as orphan drugs have been different between the 2 countries. The probabilities of development success (ie, marketing approval) in designated...

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Bibliografiske detaljer
Udgivet i:J Clin Pharmacol
Main Authors: Harada, Kenji, Toriyabe, Kazuki, Ono, Shunsuke
Format: Artigo
Sprog:Inglês
Udgivet: John Wiley and Sons Inc. 2019
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6972571/
https://ncbi.nlm.nih.gov/pubmed/31364772
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/jcph.1501
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