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
Issue number5
Publication statusPublished - 2021 May


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

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology (medical)

Cite this