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UnknownApplication of a Physiologically Based Pharmacokinetic Model to Predict OATP1B1-Related Variability in Pharmacodynamics of Rosuvastatin.
Typically, pharmacokinetic-pharmacodynamic (PK/PD) models use plasma concentration as the input that drives the PD model. However, interindividual variability in uptake transporter activity can lead to variable drug concentrations in plasma without discernible impact on the effect site organ concent...
S-EPMC4120018 | biostudies-literature
UnknownInteraction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information.
We aimed to investigate the application of combined mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation in predicting the domperidone (DOM) triggered pseudo-electrocardiogram modification in the presence of a CYP3A inhibitor, ketoconazole (KETO), using in vitro-in vivo ...
S-EPMC4150924 | biostudies-literature
UnknownAnimal versus human oral drug bioavailability: do they correlate?
Oral bioavailability is a key consideration in development of drug products, and the use of preclinical species in predicting bioavailability in human has long been debated. In order to clarify whether any correlation between human and animal bioavailability exist, an extensive analysis of the publi...
S-EPMC4107270 | biostudies-literature
UnknownNovel minimal physiologically-based model for the prediction of passive tubular reabsorption and renal excretion clearance.

Purpose

Develop a minimal mechanistic model based on in vitro-in vivo extrapolation (IVIVE) principles to predict extent of passive tubular reabsorption. Assess the ability of the model developed to predict extent of passive tubular reabsorption (Freab) and renal excretion clearan...
S-EPMC5074076 | biostudies-literature
UnknownMicrosomal and Cytosolic Scaling Factors in Dog and Human Kidney Cortex and Application for In Vitro-In Vivo Extrapolation of Renal Metabolic Clearance.
In vitro-in vivo extrapolation of drug metabolism data obtained in enriched preparations of subcellular fractions rely on robust estimates of physiologically relevant scaling factors for the prediction of clearance in vivo. The purpose of the current study was to measure the microsomal and cytosolic...
S-EPMC5399648 | biostudies-literature
UnknownPrediction of Drug-Drug Interactions Arising from CYP3A induction Using a Physiologically Based Dynamic Model.
Using physiologically based pharmacokinetic modeling, we predicted the magnitude of drug-drug interactions (DDIs) for studies with rifampicin and seven CYP3A4 probe substrates administered i.v. (10 studies) or orally (19 studies). The results showed a tendency to underpredict the DDI magnitude when ...
S-EPMC4885489 | biostudies-literature
UnknownAssessing Potential Drug-Drug Interactions Between Dabigatran Etexilate and a P-Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling.
Plasma concentrations of dabigatran, an active principle of prodrug dabigatran etexilate (DABE), are increased by renal impairment (RI) or coadministration of a P-glycoprotein inhibitor. Because the combined effects of drug-drug interactions and RI have not been evaluated by means of clinical studie...
S-EPMC6389344 | biostudies-literature
UnknownSeeing what is behind the smokescreen: A systematic review of methodological aspects of smoking interaction studies over the last three decades and implications for future clinical trials.
Smoking drug interaction studies represent a common approach for the clinical investigation of CYP1A2 induction. Despite this important role, they remain an "orphan topic" in the existing regulatory framework of drug interaction studies, and important methodological aspects remain unaddressed. The U...
S-EPMC10175975 | biostudies-literature
UnknownTranslatability of Animal Models for Alzheimer's Disease Using a Machine Learning Based Workflow.
Despite significant investment, no effective disease-modifying therapies for Alzheimer's disease (AD) have been developed to date. As understanding of the underlying causes of AD evolves, numerous animal models have been generated to study the disease. However, persistent therapeutic failures raise ...
S-EPMC12603623 | biostudies-literature
UnknownThe Influence of Drug Properties and Ontogeny of Transporters on Pediatric Renal Clearance through Glomerular Filtration and Active Secretion: a Simulation-Based Study.
Glomerular filtration (GF) and active tubular secretion (ATS) contribute to renal drug elimination, with the latter remaining understudied across the pediatric age range. Therefore, we systematically analyzed the influence of transporter ontogeny on the relative contribution of GF and ATS to renal c...
S-EPMC7306484 | biostudies-literature
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