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Covariation of Human Microsomal Protein per Gram of Liver with Age: Absence of Influence of Operator and Sample Storage May Justify Interlaboratory Data Pooling Blog Post

Scaling of metabolic clearance values from liver microsomal data or recombinantly expressed cytochrome P450 enzymes to predict human hepatic clearance requires knowledge of the amount of microsomal protein per gram…

Pharmacokinetics, Safety, and Tolerability of Teduglutide, a Glucagon-like Peptide-2 (GLP-2) Analog, Following Multiple Ascending Subcutaneous Administrations in Healthy Subjects Blog Post

Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, is currently being evaluated for the treatment of short-bowel syndrome, Crohn’s disease, and other gastrointestinal disorders. The pharmacokinetics, safety, and tolerability of teduglutide in…

Maraviroc: In Vitro Assessment of Drug-drug Interaction Potential Blog Post

AIMS: To characterize the cytochrome P450 enzyme(s) responsible for the N-dealkylation of maraviroc in vitro, and predict the extent of clinical drug-drug interactions (DDIs). METHODS: Human liver and recombinant CYP…

Meta-analysis of the Diagnostic Accuracy of Transesophageal Echocardiography for Assessment of Atherosclerosis in the Ascending Aorta in Patients Undergoing Cardiac Surgery Blog Post

Stroke after cardiac surgery may be caused by emboli emerging from an atherosclerotic ascending aorta (AA). Epiaortic ultrasound scanning (EUS), the current ‘gold’ standard for detecting AA atherosclerosis, has not…

Integrating Systems Approaches into Pharmaceutical Sciences Blog Post

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on…

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability Blog Post

This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and Bioequivalence which focused on physiological factors and variability. This conference was held at The Royal…

Intestinal Metabolism and Transport of Drugs in Children: The Effects of Age and Disease Blog Post

The presence of cytochrome P450 enzymes in the small bowel results in the reduced bioavailability of several drugs. Recently, there has been much research on the interplay between these enzymes…

Pain Relief Model for a COX-2 Inhibitor in Patients with Postoperative Dental Pain Blog Post

The aim of this study was to develop a pain relief model for a cyclooxygenase (COX)-2 inhibitor, CS-706, that permits prediction of doses for acute pain relief in Japanese and…

In Vitro Evaluation of Reversible and Irreversible Cytochrome P450 Inhibition: Current Status on Methodologies and Their Utility for Predicting Drug-drug Interactions Blog Post

It is widely accepted that today’s practice of polypharmacy inevitably increases the incidence of drug-drug interactions (DDIs). Serious DDI is a major liability for any new chemical entity (NCE) entering…

Integrated In Vitro Analysis for the In Vivo Prediction of Cytochrome P450-mediated Drug-drug Interactions Blog Post

Unbound IC50 (IC50,u) values of 15 drugs were determined in eight recombinantly expressed human cytochromes P450 (P450s) and human hepatocytes, and the data were used to simulate clinical area under the…

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