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Session Chair(s)
Bruce Morimoto, PHD
Vice President, Drug Development
United States
Learning Objective : Describe considerations in planning and implementing hepatic and renal impairment studies; Discuss the underlying pathophysiology of progressive chronic kidney disease (CKD) and chronic liver disease, associated complications, and concomitant medications; Interpret the regulatory guidances for successful study design and conduct.
Speaker(s)
Pathophysiological and Safety Issues in Special Populations Phase 1 Research
Richard A. Preston, MD, MBA, MS
University of Miami, United States
Professor, Clinical Medicine; Director, Clinical Pharmacology Research
Special Considerations in Renal and Hepatic Clinical Trials
Thomas Marbury, MD
Orlando Clinical Research Center, United States
President
FDA Perspective
Nancy Xu, MD
FDA, United States
Medical Officer, Division of Cardiovascular and Renal Products, OND, CDER
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