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Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery Blog Post

Edoxaban is an oral direct factor Xa inhibitor approved for the prevention of venous thromboembolism (VTE) in Japan. The objectives of this analysis were to characterise the population pharmacokinetics (PK)…

Designing a Clinical Drug-drug Interaction Study Blog Post

After a much longer delay that I expected, I am back to blogging on a regular basis. Today I want to discuss a common topic among clinical pharmacologists. How do…

A Pregnancy Physiologically-based Pharmacokinetic (p-PBPK) Model for Disposition of Drugs Metabolized by CYP1A2, CYP3A4, and CYP2D6 Blog Post

Pregnant women are usually not part of the traditional drug development program. Pregnancy is associated with major biological and physiological changes that alter the pharmacokinetics (PK) of drugs. Prediction of…

Ontogeny of Oral Drug Absorption Processes in Children Blog Post

A large proportion of prescribed drugs to children are administered orally. Age-related change in factors affecting oral absorption can have consequences for drug dosing. For each process affecting oral drug…

Physiologically-based Modeling of Pravastatin Transporter-mediated Hepatobiliary Disposition and Drug-drug Interactions Blog Post

To develop physiologically based pharmacokinetic (PBPK) model to predict the pharmacokinetics and drug-drug interactions (DDI) of pravastatin, using the in vitro transport parameters. In vitro hepatic sinusoidal active uptake, passive…

Methods of Solving Rapid Binding Target-mediated Drug Disposition Model for Two Drugs Competing for the Same Receptor Blog Post

The target-mediated drug disposition (TMDD) model has been adopted to describe pharmacokinetics for two drugs competing for the same receptor. A rapid binding assumption introduces total receptor and total drug concentrations while free drug concentrations C (A) and C (B) are calculated from the equilibrium (Gaddum) equations. The Gaddum equations are…

Relationship Between Prenatal Exposure to Polychlorinated Biphenyls and Birth Weight: A Systematic Analysis of Published Epidemiological Studies Through a Standardization of Biomonitoring Data Blog Post

Impact of prenatal PCB exposure on birth weight was investigated in various children cohorts and findings of published studies show inconsistencies. Because a direct comparison of results obtained from different…

Pharmacokinetic and Pharmacodynamic Analysis of Efavirenz Dose Reduction Using an In Vitro-In Vivo Extrapolation Model Blog Post

The pharmacokinetics (PK) of efavirenz (EFV) is characterized by marked inter-patient variability that correlates with its pharmacodynamics (PD). In vitro-in vivo extrapolation (IVIVE) is a “bottom-up” approach that combines drug…

Phenanthrene Metabolism in Smokers: Use of a Two-step Diagnostic Plot Approach to Identify Subjects with Extensive Metabolic Activation Blog Post

Polycyclic aromatic hydrocarbons (PAHs) in cigarette smoke are among the most likely causes of lung cancer. PAHs require metabolic activation to initiate the carcinogenic process. Phenanthrene (Phe), a noncarcinogenic PAH, was used as…

Saliva Versus Plasma Pharmacokinetics, Theory and Application of a Salivary Excretion Classification System Blog Post

The aims of this work were to study pharmacokinetics of randomly selected drugs in plasma and saliva samples in healthy human volunteers, and to introduce a Salivary Excretion Classification System….

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