Application of Physiologically Based Pharmacokinetic Modeling to Predict Drug Exposure and Support Dosing Recommendations for Potential Drug-Drug Interactions or in Special Populations: An Example Using Tofacitinib.

Tse, Susanna; Dowty, Martin E; Menon, Sujatha; Gupta, Pankaj; Krishnaswami, Sriram

Tse, Susanna; Dowty, Martin E; Menon, Sujatha; Gupta, Pankaj; Krishnaswami, Sriram.

Affiliation

Tse S; Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer Inc., Groton, Connecticut, USA.
Dowty ME; Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer Inc., Cambridge, Massachusetts, USA.
Menon S; Department of Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA.
Gupta P; Worldwide Business Development, Pfizer Inc., New York, New York, USA.
Krishnaswami S; Global Product Development, Pfizer Inc., Groton, Connecticut, USA.

J Clin Pharmacol ; 60(12): 1617-1628, 2020 12.

Article in En | MEDLINE | ID: mdl-32592424

Subject(s)

Liver Diseases/metabolism; Piperidines/pharmacokinetics; Protein Kinase Inhibitors/pharmacokinetics; Pyrimidines/pharmacokinetics; Renal Insufficiency/metabolism; Administration, Oral; Adult; Computer Simulation; Cytochrome P-450 CYP2C19/metabolism; Cytochrome P-450 CYP3A/metabolism; Cytochrome P-450 Enzyme Inducers/pharmacology; Cytochrome P-450 Enzyme Inhibitors/pharmacology; Drug Administration Schedule; Drug Interactions; Female; Healthy Volunteers; Humans; Infusions, Intravenous; Liver Diseases/physiopathology; Male; Middle Aged; Models, Biological; Piperidines/administration & dosage; Piperidines/blood; Protein Kinase Inhibitors/administration & dosage; Protein Kinase Inhibitors/blood; Pyrimidines/administration & dosage; Pyrimidines/blood; Renal Insufficiency/physiopathology; Young Adult

Key words

PBPK; Simcyp; active renal secretion; drug-drug interactions; hepatic impairment; modeling; renal impairment; tofacitinib

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Piperidines / Pyrimidines / Protein Kinase Inhibitors / Renal Insufficiency / Liver Diseases Type of study: Prognostic_studies / Risk_factors_studies Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: J Clin Pharmacol Year: 2020 Document type: Article

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