pre-update Archives

Publication

Prediction of Phase 1 Single-dose Pharmacokinetics Using Recombinant Cytochromes P450 and Physiologically-based Modeling

1. Ten compounds from the Merck Research Laboratories pipeline were selected to evaluate the utility…

CertaraSeptember 1, 2009

Publication

In Vitro Inhibition of Multiple Cytochrome P450 Isoforms by Xanthone Derivatives from Mangosteen Extract

Mangosteen is a xanthone-containing fruit found in Southeast Asia for which health claims include maintaining healthy immune…

CertaraSeptember 1, 2009

Publication

Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics

We developed a drug-disease simulation model to predict antitumor response and overall survival in phase…

CertaraSeptember 1, 2009

Publication

Excluding Venous Thromboembolism Using Point of Care D-dimer Tests in Outpatients: A Diagnostic Meta-analysis

This article is a review the evidence on the diagnostic accuracy of the currently available…

CertaraAugust 14, 2009

Publication

Comparison of Different Algorithms for Predicting Clinical Drug-drug Interactions, Based on the Use of CYP3A4 In Vitro Data: Predictions of Compounds as Precipitants of Interaction

Cytochrome P450 3A4 (CYP3A4) is the most important enzyme in drug metabolism and because it…

CertaraAugust 1, 2009

Publication

On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Drug-independent models that link biomarker response to clinical end points are critical to support early…

CertaraAugust 1, 2009

Publication

Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

Capsaicin, a pungent compound in chili peppers, is a highly selective agonist for the transient…

CertaraAugust 1, 2009

Publication

The Conduct of In Vitro Studies to Address Time-dependent Inhibition of Drug-metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America (PhRMA)

Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular entities (NMEs) is…

CertaraJuly 1, 2009

Publication

In Vitro and In Vivo Induction of Cytochrome p450: A Survey of the Current Practices and Recommendations: A Pharmaceutical Research and Manufacturers of America Perspective

Cytochrome P450 (P450) induction is one of the factors that can affect the pharmacokinetics of a drug…

CertaraJuly 1, 2009

Publication

The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions

We identify some innovative approaches to predicting overall patient benefit from investigational drugs to support…

CertaraJuly 1, 2009

pre-update

Prediction of Phase 1 Single-dose Pharmacokinetics Using Recombinant Cytochromes P450 and Physiologically-based Modeling

In Vitro Inhibition of Multiple Cytochrome P450 Isoforms by Xanthone Derivatives from Mangosteen Extract

Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics

Excluding Venous Thromboembolism Using Point of Care D-dimer Tests in Outpatients: A Diagnostic Meta-analysis

Comparison of Different Algorithms for Predicting Clinical Drug-drug Interactions, Based on the Use of CYP3A4 In Vitro Data: Predictions of Compounds as Precipitants of Interaction

On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies

Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

The Conduct of In Vitro Studies to Address Time-dependent Inhibition of Drug-metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America (PhRMA)

In Vitro and In Vivo Induction of Cytochrome p450: A Survey of the Current Practices and Recommendations: A Pharmaceutical Research and Manufacturers of America Perspective

The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions

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