Introduction: Grapefruit juice is listed by the FDA as strong inhibitor of cytochrome P450 (CYP) 3A4 [1] which metabolizes up…
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Physiologically based pharmacokinetic modeling of amitriptyline and its active metabolite nortriptyline to investigate CYP2D6 and CYP2C19 mediated drug-drug and drug-gene interactions
Introduction: The tricyclics amitriptyline and nortriptyline are both indicated for the treatment of several conditions, including depressive disorders or neuropathic…
Read moreParent-Metabolite Physiologically Based Pharmacokinetic Modeling of Mirtazapine during Drug-Drug- and Drug-Gene-Interactions
Introduction: The racemate mirtazapine, used in treatment of major depressive disorders, is metabolized by several cytochrome P450 (CYP) enzymes, predominantly…
Read morePhysiologically-based pharmacokinetic modeling of drug-drug interactions with ketoconazole and its metabolite deacetyl-ketoconazole
Introduction: The antimycotic drug ketoconazole is well known for its strong drug-drug interaction (DDI) potential [1]. As a substrate and…
Read morePhysiologically-based pharmacokinetic modeling of DPYD substrate 5-fluorouracil and its prodrug capecitabine
Introduction: The intravenously administered cytotoxic drug 5-fluorouracil (5-FU) and its oral prodrug capecitabine (CCB) are used as first line agents…
Read moreDevelopment and Evaluation of a Human Physiologically Based Pharmacokinetic Model to Assess a Mitigation Strategy for Risks Associated with Novel Monoclonal Antibodies
Introduction: Creation of molecules that provide more optimal characteristics for consumers continuously evolves in the drug development industry. Monoclonal antibodies…
Read morePopulation Pharmacokinetics (PK) and pharmacodynamics (PD) Modeling of anti-avß6 integrin Antibody (BG00011)
Introduction: Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease caused by progressive scarring in the lungs tissue [1]. To…
Read moreOptimizing FOLFIRINOX regimen in pancreatic adenocarcinoma using a 5FU-PKPD model of neutropenia including G-CSF rescue
Objectives: Pancreatic adenocarcinoma is one of the most lethal human malignancies and a major health issue. FOLFIRINOX regimen is commonly…
Read morePopulation pharmacokinetic analysis of eliglustat in pediatric patients with Gaucher disease
Introduction: Gaucher disease (GD) is an autosomal recessive lysosomal storage disease that results from a deficiency of acid β-glucosidase. The…
Read moreA virtual ulcerative colitis patient population to explore combination treatments in in silico clinical trials
Objectives: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD). Advanced treatment options with biologics only achieve clinical remission…
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