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Cytochrome P450 3A Expression and Activity in the Human Small Intestine Blog Post

Recently, von Richter et al measured the content of cytochrome P450 (CYP) 3A in paired samples of human enterocytes and liver tissue. We now report calculations that we believe enhance…

Prediction of Clearance from Recombinantly Expressed CYPs: Intersystem Extrapolation Factor (ISEF) Blog Post

Recombinantly expressed human cytochromes P450 (rhCYPs) have been underused for the prediction of human drug clearance (CL). Differences in intrinsic activity (per unit CYP) between rhCYP and human liver enzymes…

The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain Blog Post

Pregabalin is being evaluated for the treatment of neuropathic pain. Two phase 2 studies were simulated to determine how precisely the dose that caused a one-point reduction in the pain…

The Effects of Dose Staggering on Metabolic Drug-drug Interactions Blog Post

The purpose of this study was to investigate the effect of dose staggering on metabolic drug-drug interactions (MDDI). Using Matlab®, anatomical, physiological and biochemical data relating to human pharmacokinetics were…

Pharmacokinetics of Melagatran and the Effect on Ex Vivo Coagulation Time in Orthopedic Surgery Patients Receiving Subcutaneous Melagatran and Oral Ximelagatran: A Population Model Analysis Blog Post

Ximelagatran, an oral direct thrombin inhibitor, is rapidly bioconverted to melagatran, its active form. The objective of this population analysis was to characterise the pharmacokinetics of melagatran and its effect…

A Population Pharmacokinetic/Pharmacodynamic Analysis of Repeated Measures Time-to-event Pharmacodynamic Responses: The Antiemetic Effect of Ondansetron Blog Post

This paper presents and illustrates methodology for specifying, estimating, and evaluating a predictive model for repeated measures time-to-event responses. The illustrative example specifies a model of the antiemetic effect vs….

The Determination of Drug Metabolizing Enzyme Activity In Vivo: Pharmacokinetics and Statistical Issues Blog Post

Probe substrates for various isoforms of cytochrome P450 and other drug-metabolizing enzymes are now widely used to assess genetic, environmental and ethnic differences in the in vivo metabolism of drugs…

The future of Parkinson’s disease research: A new paradigm of human-specific investigation is necessary… and possible Blog Post

Abstract Parkinson’s disease (PD) is a complex neurodegenerative condition with a multifactorial origin. To date, approaches to drug discovery for PD have resulted in symptomatic therapies for the motor manifestations...