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

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

Research output: Contribution to journalComment/debatepeer-review

Original languageEnglish
Pages (from-to)434-439
Number of pages6
JournalClinical Pharmacology in Drug Development
Volume10
Issue number5
DOIs
Publication statusPublished - 2021 May
Externally publishedYes

Keywords

  • bridging strategy
  • clinical study
  • drug development
  • drug lag
  • new drug application

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology (medical)

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