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By: United States) Huang MD Food and Drug Administration (FDA) Silver Spring Center for Drug Evaluation Research (CDER) Office of Clinical Pharmacology (OCP) Shiew-Mei (Deputy Director (Author) , United States) Lertora NC Durham Duke UniversitySchool of Medicine Department of Medicine United States<br>Adjunct Professor LA Baton Rouge Louisiana State University Pennington Biomedical Research Center Division of Clinical Research Juan J.L. (Adjunct Professor (Author) , Belgium) Vicini Ghent Confo Therapeutics NV Paolo (Chief Development Officer (Author)
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