Model Informed Drug Development Archives

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

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

Publication

Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power

The clinical assessment of metabolic drug-drug interactions (mDDI) may involve population-based pharmacokinetic (POPPK) assessment as…

CertaraJuly 1, 2009

Publication

In Vitro and In Silico Identification and Characterization of Thiabendazole as a Mechanism-based Inhibitor of CYP1A2 and Simulation of Possible Pharmacokinetic Drug-drug Interactions

Thiabendazole (TBZ) and its major metabolite 5-hydroxythiabendazole (5OH-TBZ) were screened for potential time-dependent inhibition (TDI) against CYP1A2.…

CertaraJune 1, 2009

Publication

Population-based Mechanistic Prediction of Oral Drug Absorption

The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal…

CertaraJune 1, 2009

Model Informed Drug Development

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

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

Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power

In Vitro and In Silico Identification and Characterization of Thiabendazole as a Mechanism-based Inhibitor of CYP1A2 and Simulation of Possible Pharmacokinetic Drug-drug Interactions

Population-based Mechanistic Prediction of Oral Drug Absorption

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