Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics.

Autor: Hyland PL; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Chekka LMS; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Samarth DP; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Rosenzweig BA; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Decker E; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Mohamed EG; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Guo Y; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Matta MK; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Sun Q; Therapeutic Biologics Protein Team, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wheeler W; Information Management Services, Inc., Rockville, Maryland, USA., Sanabria C; Spaulding Clinical Research, West Bend, Wisconsin, USA., Weaver JL; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Schrieber SJ; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Florian J; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wang YM; Therapeutic Biologics Protein Team, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Strauss DG; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2023 Jan; Vol. 113 (1), pp. 98-107. Date of Electronic Publication: 2022 Nov 19.

Genetic Contributors of Efficacy and Adverse Metabolic Effects of Chlorthalidone in African Americans from the Genetics of Hypertension Associated Treatments (GenHAT) Study.

Autor: Armstrong ND; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Srinivasasainagendra V; Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Chekka LMS; Division of Applied Regulatory Sciences, Center for Drug Evaluation and Research, Silver Spring, MD 20903, USA., Nguyen NHK; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA., Nahid NA; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA., Jones AC; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA.; Medical Scientist Training Program, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Tanner RM; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Hidalgo BA; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Limdi NA; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Claas SA; Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, KY 40506, USA., Gong Y; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA., McDonough CW; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA., Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA.; Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL 32611, USA., Johnson JA; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL 32611, USA.; Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL 32611, USA., Tiwari HK; Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Arnett DK; Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, KY 40506, USA.; Deans Office, College of Public Health, University of Kentucky, Lexington, KY 40506, USA., Irvin MR; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA.

Publikováno v: Genes [Genes (Basel)] 2022 Jul 15; Vol. 13 (7). Date of Electronic Publication: 2022 Jul 15.

Race-Specific Comparisons of Antihypertensive and Metabolic Effects of Hydrochlorothiazide and Chlorthalidone.

Autor: Chekka LMS; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida., Chapman AB; Division of Nephrology, University of Chicago, Illinois., Gums JG; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida., Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida; Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, Florida., Johnson JA; Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida; Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, Florida. Electronic address: julie.johnson@ufl.edu.

Publikováno v: The American journal of medicine [Am J Med] 2021 Jul; Vol. 134 (7), pp. 918-925.e2. Date of Electronic Publication: 2021 Jan 09.