Model Informed Drug Development Archives

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

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

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

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…

Certara2009 年 7 月 1 日

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…

Certara2009 年 7 月 1 日

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.…

Certara2009 年 6 月 1 日

Publication

Population-based Mechanistic Prediction of Oral Drug Absorption

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

Certara2009 年 6 月 1 日

Publication

Towards a Quantitative Framework for the Prediction of DDIs Arising from Cytochrome P450 Induction

Although CYP induction is not generally considered to be as clinically relevant as CYP inhibition,…

Certara2009 年 5 月 1 日

Publication

In Vitro and In Vivo Glucuronidation of Midazolam in Humans

Midazolam (MDZ) is a benzodiazepine used as a CYP3A4 probe in clinical and in vitro studies. A…

Certara2009 年 4 月 1 日

Publication

Bioavailability and Tolerability of Intranasal Diazepam in Healthy Adult Volunteers

Intranasal therapy has been proposed as an alternative for the management of seizure emergencies. The…

Certara2009 年 4 月 1 日

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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

Towards a Quantitative Framework for the Prediction of DDIs Arising from Cytochrome P450 Induction

In Vitro and In Vivo Glucuronidation of Midazolam in Humans

Bioavailability and Tolerability of Intranasal Diazepam in Healthy Adult Volunteers

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