Understanding CYP2D6 Interactions
Owing to the polymorphic nature of CYP2D6, clinically significant issues can arise when drugs rely…
webdev2009 年 10 月 1 日
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…
webdev2009 年 9 月 1 日
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…
webdev2009 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
Cytochrome P450 3A4 (CYP3A4) is the most important enzyme in drug metabolism and because it…
webdev2009 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
Drug-independent models that link biomarker response to clinical end points are critical to support early…
webdev2009 年 8 月 1 日
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…
webdev2009 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)
Time-dependent inhibition (TDI) of cytochrome P450 (P450) enzymes caused by new molecular entities (NMEs) is…
webdev2009 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
Cytochrome P450 (P450) induction is one of the factors that can affect the pharmacokinetics of a drug…
webdev2009 年 7 月 1 日
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…
webdev2009 年 7 月 1 日
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…
webdev2009 年 7 月 1 日
