Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials-Reference-Cited by-同舟云学术

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials

Published:2019-03-28 Issue:6 Volume:85 Page:1270-1282
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Sai Kimie¹^ORCID,Yoshida Akiomi²,Hanatani Tadaaki¹,Imatoh Takuya¹^ORCID,Takeuchi Masahiro²,Narukawa Mamoru³,Watanabe Hiroshi⁴⁵,Uyama Yoshiaki⁶,Saito Yoshiro¹

Affiliation:

1. Division of Medicinal Safety ScienceNational Institute of Health Sciences Kawasaki Japan

2. Department of Clinical Medicine (Biostatistics), School of PharmacyKitasato University Tokyo Japan

3. Department of Clinical Medicine (Pharmaceutical Medicine), School of PharmacyKitasato University Tokyo Japan

4. Department of Clinical Pharmacology and TherapeuticsHamamatsu University School of Medicine Hamamatsu Japan

5. Center of Clinical SciencesNational Center for Global Health and Medicine Tokyo Japan

6. Office of Medical Informatics and EpidemiologyPharmaceuticals & Medical Devices Agency Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.13893

Reference19 articles.

1. Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors

2. Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects

3. Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective

4. Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

5. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Ethnic factors in the acceptability a foreign clinical data E5 (R1). c1998 [cited 1998 February 5] Available from:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E5_R1/Step4/E5_R1__Guideline.pdf.

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