Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor Publication Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide) is a potent, selective Hedgehog (Hh) signalling pathway inhibitor being developed for the…Certara2009 年 11 月 1 日
Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Publication Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Concentration-QT (C-QT) modeling has been conducted for multiple compounds at various stages of development in…Certara2009 年 11 月 1 日
Understanding CYP2D6 Interactions Publication Understanding CYP2D6 Interactions Owing to the polymorphic nature of CYP2D6, clinically significant issues can arise when drugs rely…Certara2009 年 10 月 1 日
Prediction of Phase 1 Single-dose Pharmacokinetics Using Recombinant Cytochromes P450 and Physiologically-based Modeling 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…Certara2009 年 9 月 1 日
Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics 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…Certara2009 年 9 月 1 日
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 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…Certara2009 年 8 月 1 日
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 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…Certara2009 年 8 月 1 日
Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain 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…Certara2009 年 8 月 1 日
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) 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…Certara2009 年 7 月 1 日
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 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…Certara2009 年 7 月 1 日