Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan

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Veröffentlicht in:Clinical pharmacology in drug development 2021-05, Vol.10 (5), p.434-439
Hauptverfasser: Asada, Ryuta, Shimizu, Shinobu, Nakamura, Harumasa, Ono, Shunsuke, Yamaguchi, Takuhiro
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creator Asada, Ryuta
Shimizu, Shinobu
Nakamura, Harumasa
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doi_str_mv 10.1002/cpdd.942
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects bridging strategy
clinical study
Drug Approval - statistics & numerical data
drug development
Drug Development - methods
Drug Industry - methods
drug lag
Guidelines as Topic
Humans
Internationality
Japan
new drug application
title Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan
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