Dibutylphthalate (DBP) can cause adverse effects on the developing male reproductive tract when administered late in gestation to pregnant rats. The objectives of this study were to evaluate the metabolism…
Drug/metabolite ratios (MRs) are used as in vivo markers of enzyme activity. The ratios are potentially confounded by the renal clearance of the drug (urine-based MRs) or metabolite (plasma-based MRs)….
Recently, Andersson et al. (2004) reported that quantitative predictions of hepatic clearance from in vitro CLint values using the “well- stirred liver” model were not useful. Over-prediction of in vivo…
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…
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…
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 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…
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…
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….
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…
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