Physiologically‐Based Pharmacokinetic Modeling Characterizes the CYP3A‐Mediated Drug‐Drug Interaction Between Fluconazole and Sildenafil in Infants

Author:

Salerno Sara N.1,Edginton Andrea2,Gerhart Jacqueline G.1,Laughon Matthew M.3,Ambalavanan Namasivayam4,Sokol Gregory M.5,Hornik Chi D.678,Stewart Dan9,Mills Mary7,Martz Karen10,Gonzalez Daniel1,Benjamin Jr Daniel K,Hornik Christoph,Zimmerman Kanecia,Kennel Phyllis,Beci Rose,Hornik Chi Dang,Kearns Gregory L,Laughon Matthew,Paul Ian M,Sullivan Janice,Wade Kelly,Delmore Paula,Kennedy Eunice,Taylor‐Zapata Perdita,Lee. June,Anand Ravinder,Sharma Gaurav,Simone Gina,Kaneshige Kim,Taylor Lawrence,Green Thomas,Lurie Robert H.,Ambalavanan Namasivayam,McNair Tara E,Phillips Vivien,Atz Andrew,Choudhary Kalyan Janakiram,Sokol Gregory M,Gunn Susan,Herron Dianne,Smiley Lucy,Hornik Chi D,Michael Cotten C.,Andrews Lacey,Stewart Dan,Sullivan Janice,Michael Andrew,Mundakel Gratias,Limbu Subhatra,Poindexter Brenda,Wuertz Sandra,

Affiliation:

1. Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

2. School of Pharmacy University of Waterloo Kitchener Ontario Canada

3. Department of Pediatrics UNC School of Medicine The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

4. Division of Neonatology School of Medicine University of Alabama at Birmingham Birmingham Alabama USA

5. Division of Neonatal‐Perinatal Medicine Indiana University School of Medicine Indianapolis Indiana USA

6. Department of Pediatrics Duke University School of Medicine Durham North Carolina USA

7. Duke Clinical Research Institute Durham North Carolina USA

8. Department of Pharmacy Duke University Medical Center Durham North Carolina USA

9. University of Louisville Norton Children’s Hospital Louisville Kentucky USA

10. The Emmes Company, LLC Rockville Maryland USA

Funder

National Institute of Child Health and Human Development

National Institute of General Medical Sciences

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference50 articles.

1. US Food and Drug Administration Center for Drug Evaluation and Research.Clinical drug interaction studies‐cytochrome P450 enzyme‐ and transporter‐mediated drug interactions. Guidance for industry (2020). Accessed August 5 2020.

2. Developmental Expression of the Major Human Hepatic CYP3A Enzymes

3. CYP3A7 protein expression is high in a fraction of adult human livers and partially associated with the CYP3A7*1C allele

4. Comparative Metabolic Capabilities of CYP3A4, CYP3A5, and CYP3A7

5. Inhibition of cytochrome P‐450 3A (CYP3A) in human intestinal and liver microsomes: comparison of Ki values and impact of CYP3A5 expression;Gibbs M.A.;Drug Metab. Dispos.,1999

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