Model Informed Drug Development Archives

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

Publication

Sources of Interindividual Variability in IVIVE of Clearance: An Investigation into the Prediction of Benzodiazepine Clearance Using a Mechanistic Population-based Pharmacokinetic Model

Prediction of metabolic clearance in extreme individuals rather than the 'average human' is becoming an…

Certara2011年3月24日

Publication

Utility of Intersystem Extrapolation Factors in Early Reaction Phenotyping and the Quantitative Extrapolation of Human Liver Microsomal Intrinsic Clearance Using Recombinant Cytochromes P450

Reaction phenotyping using recombinant human cytochromes P450 (P450) has great utility in early discovery. However,…

Certara2011年3月1日

Publication

Casopitant: In Vitro Data and Simcyp Simulation to Predict In Vivo Metabolic Interactions Involving Cytochrome P450 3A4

has previously been shown to be a potent and selective antagonist of the human neurokinin-1…

Certara2011年3月1日

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モデルに基づく医薬品開発

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

Sources of Interindividual Variability in IVIVE of Clearance: An Investigation into the Prediction of Benzodiazepine Clearance Using a Mechanistic Population-based Pharmacokinetic Model

Utility of Intersystem Extrapolation Factors in Early Reaction Phenotyping and the Quantitative Extrapolation of Human Liver Microsomal Intrinsic Clearance Using Recombinant Cytochromes P450

Casopitant: In Vitro Data and Simcyp Simulation to Predict In Vivo Metabolic Interactions Involving Cytochrome P450 3A4

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