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Asada R, Shimizu S, Nakamura H, et al. Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan. Clin Pharmacol Drug Dev. 2021;10(5):434-439doi: 10.1002/cpdd.942.
Asada, R., Shimizu, S., Nakamura, H., Ono, S., & Yamaguchi, T. (2021). Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan. Clinical pharmacology in drug development, 10(5), 434-439. https://doi.org/10.1002/cpdd.942
Asada, Ryuta, et al. "Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan." Clinical pharmacology in drug development vol. 10,5 (2021): 434-439. doi: https://doi.org/10.1002/cpdd.942
Asada R, Shimizu S, Nakamura H, Ono S, Yamaguchi T. Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan. Clin Pharmacol Drug Dev. 2021 May;10(5):434-439. doi: 10.1002/cpdd.942. Epub 2021 Mar 30. PMID: 33787062.
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Clin Pharmacol Drug Dev. 2021 May;10(5):434-439. doi: 10.1002/cpdd.942. Epub 2021 Mar 30.

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

Clinical pharmacology in drug development

Ryuta Asada, Shinobu Shimizu, Harumasa Nakamura, Shunsuke Ono, Takuhiro Yamaguchi

Affiliations

  1. Innovative and Clinical Research Promotion Center, Gifu University Hospital, Gifu, Japan.
  2. Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
  3. Translational Medical Center, National Center of Neurology and Psychiatry, Tokyo, Japan.
  4. Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.
  5. Department of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.

PMID: 33787062 DOI: 10.1002/cpdd.942

[No abstract available.]

Keywords: bridging strategy; clinical study; drug development; drug lag; new drug application

References

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