Scientific considerations for global drug development

Author:

Wilson Jennifer L.1ORCID,Cheung Kit Wun Kathy1ORCID,Lin Lawrence1ORCID,Green Elizabeth A. E.1,Porrás Analia I.2ORCID,Zou Ling1ORCID,Mukanga David3ORCID,Akpa Paul A.4,Darko Delese Mimi5,Yuan Rae6,Ding Sheng78,Johnson Wiltshire C. N.9,Lee Howard A.1011,Cooke Emer12,Peck Carl C.113ORCID,Kern Steven E.3ORCID,Hartman Dan3ORCID,Hayashi Yoshikazu14,Marks Peter W.15ORCID,Altman Russ B.16ORCID,Lumpkin Murray M.3ORCID,Giacomini Kathleen M.1ORCID,Blaschke Terrence F.17ORCID

Affiliation:

1. Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

2. Medicines and Health Technologies Unit, Department of Health Systems and Services, Pan American Health Organization, Regional Office of the World Health Organization, Washington, DC, USA.

3. Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.

4. Department of Pharmaceutics, University of Nigeria, Nsukka, Enugu State, Nigeria.

5. Food and Drugs Authority, Accra, Ghana.

6. Sinovant Sciences Co., Shanghai, China.

7. School of Pharmaceutical Sciences, Tsinghua University, Beijing, China.

8. Gladstone Institute of Cardiovascular Disease, San Francisco, CA, USA.

9. Pharmacy Board of Sierra Leone, Freetown, Sierra Leone.

10. Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.

11. Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Suwon, Republic of Korea.

12. World Health Organization, Geneva, Switzerland.

13. NDA Partners LLC, San Luis Obispo, CA, USA.

14. Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

15. Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

16. Departments of Bioengineering and Genetics, Stanford University, Stanford, CA, USA.

17. Departments of Medicine and Molecular Pharmacology, Stanford University School of Medicine, Stanford, CA, USA.

Abstract

Scientific and technological advances could reduce the need for in-country or in-region confirmatory clinical trials.

Funder

U.S. Food and Drug Administration

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference31 articles.

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