Model Informed Drug Development Archives

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…

CertaraSeptember 1, 2011

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…

CertaraAugust 1, 2011

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…

CertaraAugust 1, 2011

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…

CertaraJuly 1, 2011

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…

CertaraJune 14, 2011

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…

CertaraJune 1, 2011

Publication

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

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

CertaraMay 11, 2011

Publication

Beyond Publication Bias

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

CertaraMay 1, 2011

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…

CertaraMay 1, 2011

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…

CertaraMay 1, 2011

Model Informed Drug Development

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

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

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