Model Informed Drug Development Archives

Publication

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

Scaling of metabolic clearance values from liver microsomal data or recombinantly expressed cytochrome P450 enzymes…

CertaraDecember 1, 2008

Publication

Maraviroc: In Vitro Assessment of Drug-drug Interaction Potential

AIMS: To characterize the cytochrome P450 enzyme(s) responsible for the N-dealkylation of maraviroc in vitro,…

CertaraOctober 1, 2008

Publication

Integrating Systems Approaches into Pharmaceutical Sciences

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and…

CertaraSeptember 2, 2008

Publication

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and…

CertaraAugust 1, 2008

Publication

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

The aim of this study was to develop a pain relief model for a cyclooxygenase…

CertaraJuly 1, 2008

Publication

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

It is widely accepted that today's practice of polypharmacy inevitably increases the incidence of drug-drug…

CertaraJune 1, 2008

Publication

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

Unbound IC50 (IC50,u) values of 15 drugs were determined in eight recombinantly expressed human cytochromes P450…

CertaraJune 1, 2008

Publication

Application of CYP3A4 In Vitro Data to Predict Clinical Drug-drug Interactions: Predictions of Compounds as Objects of Interaction

Numerous retrospective analyses have shown the utility of in vitro systems for predicting potential drug-drug interactions (DDIs). Prediction of DDIs…

CertaraMay 1, 2008

Publication

Comparison of Different Approaches to Predict Metabolic Drug-drug Interactions

Three approaches were compared to predict the actual magnitude of drug interaction (the mean fold-change in the area under…

CertaraOctober 1, 2007

Publication

Prediction of Intestinal First-pass Drug Metabolism

Despite a lower content of many drug metabolising enzymes in the intestinal epithelium compared to…

CertaraOctober 1, 2007

Model Informed Drug Development

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

Maraviroc: In Vitro Assessment of Drug-drug Interaction Potential

Integrating Systems Approaches into Pharmaceutical Sciences

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

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

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

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

Application of CYP3A4 In Vitro Data to Predict Clinical Drug-drug Interactions: Predictions of Compounds as Objects of Interaction

Comparison of Different Approaches to Predict Metabolic Drug-drug Interactions

Prediction of Intestinal First-pass Drug Metabolism

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