Research Data from EMD Serono Research and Development Institute Inc. Update Understanding of Drug Development (Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives:...).

Předmět:	CLINICAL pharmacology DRUG development RESEARCH institutes RESEARCH & development PHARMACEUTICAL biotechnology industry
Zdroj:	Medical Letter on the CDC & FDA; 7/26/2024, p1511-1511, 1p
Abstrakt:	A recent report from the EMD Serono Research and Development Institute Inc. discusses the role of clinical pharmacology in promoting diversity and inclusion in global drug development. The report highlights the efforts of the United States Food and Drug Administration (FDA) to ensure that registrational studies reflect diverse patient populations. It emphasizes the use of quantitative pharmacology to support the inclusion of underrepresented populations in clinical trials and provides recommendations for integrating demographics in multiregional phase III studies. The report also addresses the challenges faced in global drug development and envisions a future where drug labels accurately represent the intended patient populations. [Extracted from the article]
Databáze:	Complementary Index
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