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 |
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container_title | Clinical pharmacology in drug development |
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creator | Asada, Ryuta Shimizu, Shinobu Nakamura, Harumasa Ono, Shunsuke Yamaguchi, Takuhiro |
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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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