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…

Certara2011 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…

Certara2011 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…

Certara2011 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…

Certara2011 年 6 月 1 日

Publication

Systems Pharmacology: Bridging Systems Biology and (PK/PD)

Mechanistic PKPD models are now advocated not only by academic and industrial researchers, but also…

Certara2011 年 5 月 11 日

Publication

Beyond Publication Bias

In drug development, clinical medicine, or health policy making, basing one's decisions on a selective…

Certara2011 年 5 月 1 日

Publication

The Development of UGT1A1 and 1A6 in the Pediatric Liver

UDP-glucuronosyltransferases (UGTs) are critical for the metabolism and clearance of drugs, chemicals, and hormones. The…

Certara2011 年 5 月 1 日

Publication

Towards a Better Prediction of Peak Concentration, Volume of Distribution, and Half-life After Oral Drug Administration in Man, Using Allometry

It is imperative that new drugs demonstrate adequate pharmacokinetic properties, allowing an optimal safety margin…

Certara2011 年 5 月 1 日

Publication

Estimating Toxicity-related Biological Pathway Altering Doses for High-throughput Chemical Risk Assessment

We describe a framework for estimating the human dose at which a chemical significantly alters…

Certara2011 年 4 月 18 日

Publication

In Silico Prediction of Efavirenz and Rifampicin Drug-drug Interaction Considering Weight and CYP2B6 Phenotype

This study aimed to test whether a pharmacokinetic simulation model could extrapolate nonclinical drug data…

Certara2011 年 4 月 1 日

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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

Systems Pharmacology: Bridging Systems Biology and (PK/PD)

Beyond Publication Bias

The Development of UGT1A1 and 1A6 in the Pediatric Liver

Towards a Better Prediction of Peak Concentration, Volume of Distribution, and Half-life After Oral Drug Administration in Man, Using Allometry

Estimating Toxicity-related Biological Pathway Altering Doses for High-throughput Chemical Risk Assessment

In Silico Prediction of Efavirenz and Rifampicin Drug-drug Interaction Considering Weight and CYP2B6 Phenotype

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