Scientific considerations for global drug development.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 32727913.
- Also identified by DOI 10.1126/scitranslmed.aax2550 and PMC identifier 8158457.
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Abstract
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.
Medical subject headings
- Developing Countries
- Drug Costs