Transl Clin Pharmacol.  2018 Sep;26(3):101-102. 10.12793/tcp.2018.26.3.101.

Regional clinical pharmacology trials for Multi-Regional clinical trials

Affiliations
  • 1Department of Clinical Pharmacology and Therapeutics College of Medicine, Seoul National University and Seoul National University Hospital, Clinical Trials Center, SNU Hospital, Seoul 03080, Korea. ijjang@snu.ac.kr

Abstract

No abstract available.


MeSH Terms

Pharmacology, Clinical*

Figure

  • Figure 1 Illustrations of clinical drug development workflow across regions for drug submission and regulatory review in independent and global strategies.[2] *Marketing Authorization Application/New Drug Application, **Could be parallel single region trials or MRCTs.


Reference

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