Model Informed Drug Development Archives

Publication

Safety and Population Pharmacokinetic Analysis of Intravenous Acetaminophen in Neonates, Infants, Children, and Adolescents with Pain or Fever

The administration of acetaminophen via the oral and rectal routes may be contraindicated in specific…

webdev2011 年 10 月 16 日

Publication

Risk Assessment of Accidental Nortriptyline Poisoning: The Importance of Cytochrome P450 for Nortriptyline Elimination Investigated Using a Population-based Pharmacokinetic Simulator

It is not possible to make a prospective clinical study that reveals the importance of…

webdev2011 年 10 月 9 日

Publication

Evaluation of Combined Bevacizumab and Intraperitoneal Carboplatin or Paclitaxel Therapy in a Mouse Model of Ovarian Cancer

The purpose of this was to evaluate the pharmacokinetics of bevacizumab following IP and IV…

webdev2011 年 10 月 1 日

Publication

Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors

SN2310 is an injectable emulsion composed of vitamin E, a succinate derivative, as well as…

webdev2011 年 10 月 1 日

Publication

Are There Differences in the Catalytic Activity per Unit Enzyme of Recombinantly Expressed and Human Liver Microsomal Cytochrome P4502C9? A Systematic Investigation into Inter-system Extrapolation Factors

The 'relative activity factor' (RAF) compares the activity per unit of microsomal protein in recombinantly…

webdev2011 年 9 月 1 日

Publication

Effects of the Moderate CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fesoterodine in Healthy Subjects

Available data suggest that fesoterodine dosage should not exceed 4 mg once daily when taken…

webdev2011 年 8 月 1 日

Publication

Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate

Twenty four hour ammonia profiles and correlates of drug effect were examined in a phase…

webdev2011 年 8 月 1 日

Publication

Simulation of Clinical Drug-drug Interactions from Hepatocyte CYP3A4 Induction Data and Its Potential Utility in Trial Designs

Rifampin and carbamazepine have been recommended in the U.S. Food and Drug Administration draft drug…

webdev2011 年 7 月 1 日

Publication

Prediction of Time-dependent CYP3A4 Drug-drug Interactions by Physiologically-based Pharmacokinetic Modeling: Impact of Inactivation Parameters and Enzyme Turnover

Predicting the magnitude of time-dependent metabolic drug-drug (mDDIs) interactions involving cytochrome P-450 3A4 (CYP3A4) from…

webdev2011 年 6 月 14 日

Publication

Model-based Development of Anacetrapib, a Novel Cholesteryl Ester Transfer Protein Inhibitor

A model-based strategy was used to inform the early clinical development of anacetrapib, a novel…

webdev2011 年 6 月 1 日

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Safety and Population Pharmacokinetic Analysis of Intravenous Acetaminophen in Neonates, Infants, Children, and Adolescents with Pain or Fever

Risk Assessment of Accidental Nortriptyline Poisoning: The Importance of Cytochrome P450 for Nortriptyline Elimination Investigated Using a Population-based Pharmacokinetic Simulator

Evaluation of Combined Bevacizumab and Intraperitoneal Carboplatin or Paclitaxel Therapy in a Mouse Model of Ovarian Cancer

Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors

Are There Differences in the Catalytic Activity per Unit Enzyme of Recombinantly Expressed and Human Liver Microsomal Cytochrome P4502C9? A Systematic Investigation into Inter-system Extrapolation Factors

Effects of the Moderate CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fesoterodine in Healthy Subjects

Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate

Simulation of Clinical Drug-drug Interactions from Hepatocyte CYP3A4 Induction Data and Its Potential Utility in Trial Designs

Prediction of Time-dependent CYP3A4 Drug-drug Interactions by Physiologically-based Pharmacokinetic Modeling: Impact of Inactivation Parameters and Enzyme Turnover

Model-based Development of Anacetrapib, a Novel Cholesteryl Ester Transfer Protein Inhibitor

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