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Scientific considerations for global drug development
- Wilson, Jennifer L;
- Cheung, Kit Wun Kathy;
- Lin, Lawrence;
- Green, Elizabeth AE;
- Porrás, Analia I;
- Zou, Ling;
- Mukanga, David;
- Akpa, Paul A;
- Darko, Delese Mimi;
- Yuan, Rae;
- Ding, Sheng;
- Johnson, Wiltshire CN;
- Lee, Howard A;
- Cooke, Emer;
- Peck, Carl C;
- Kern, Steven E;
- Hartman, Dan;
- Hayashi, Yoshikazu;
- Marks, Peter W;
- Altman, Russ B;
- Lumpkin, Murray M;
- Giacomini, Kathleen M;
- Blaschke, Terrence F
- et al.
Published Web Location
https://doi.org/10.1126/scitranslmed.aax2550Abstract
Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.
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