Heterogeneity in treatment effects across diverse populations

Author:

Nugent Bridget M.1ORCID,Madabushi Rajanikanth2,Buch Barbara3,Peiris Vasum4,Crentsil Victor5ORCID,Miller Virginia M.6,Bull Jonca7,Jenkins Marjorie1

Affiliation:

1. Office of Women's Health U.S. Food and Drug Administration Silver Spring Maryland USA

2. Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA

3. Center for Biologics Evaluation & Research U.S. Food and Drug Administration Silver Spring Maryland USA

4. Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring Maryland USA

5. Office of Drug Evaluation III, Office of New Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA

6. Departments of Surgery, and Physiology and Bioengineering Mayo Clinic Rochester Minnesota USA

7. Global Product Development PPDi Wilmington North Carolina USA

Funder

Center of Excellence in Regulatory Science and Innovation

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference36 articles.

1. U.S. Food and Drug Administration. FDA Mission Statement.https://www.fda.gov/about-fda/what-we-do

2. U.S. Food and Drug Administration.Federal Food Drug and Cosmetics Act. 2013;Sec. 201(g)(1).

3. Clinical pharmacology - the first 75 years and a view of the future

4. Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

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