Model Informed Drug Development Archives

Publication

Effects of Omeprazole and Genetic Polymorphism of CYP2C19 on the Clopidogrel Active Metabolite

Clopidogrel is an antiplatelet agent widely used in cardiovascular diseases and an inactive prodrug that…

webdev2012年1月1日

Publication

Application of PBPK Modeling in Drug Discovery and Development at Pfizer

Early prediction of human pharmacokinetics (PK) and drug-drug interactions (DDI) in drug discovery and development…

webdev2012年1月1日

Publication

γ-hydroxybutyrate Blood/Plasma Partitioning: Effect of Physiologic pH on Transport by Monocarboxylate Transporters

The drug of abuse γ-hydroxybutyrate (GHB) displays nonlinear renal clearance, which has been attributed to…

webdev2012年1月1日

Publication

ST Analysis of the Fetal Electrocardiogram in Intrapartum Fetal Monitoring: A Meta-analysis

The objective of this study was to compare the effects of ST-waveform analysis in combination…

webdev2012年1月1日

Publication

Exposure-response Relationship of AMG 386 in Combination with Weekly Paclitaxel in Recurrent Ovarian Cancer and Its Implication for Dose Selection

The purpose of this study was to characterize exposure–response relationships of AMG 386 in a…

webdev2012年1月1日

Publication

Pre-clinical Metabolism and Disposition of SB939 (Pracinostat), an Orally Active Histone Deacetylase Inhibitor, and Prediction of Human Pharmacokinetics

The preclinical absorption, distribution, metabolism, and excretion (ADME) properties of Pracinostat -1H-benzimidazol-5-yl]-N-hydroxyarylamide hydrochloride; SB939], an…

webdev2011年12月1日

Publication

Influence of Mild and Moderate Hepatic Impairment on Axitinib Pharmacokinetics

To evaluate the effects of hepatic impairment on the pharmacokinetics and safety of a single,…

webdev2011年12月1日

Publication

Effect of Microgravity on the Pharmacokinetics of Ibuprofen in Humans

The pharmacokinetics of ibuprofen were studied under microgravity (µG) conditions and compared with those at…

webdev2011年12月1日

Publication

Population Pharmacokinetic-pharmacodynamic-disease Progression Model for Effects of Anakinra in Lewis Rats with Collagen-induced Arthritis

A population pharmacokinetic-pharmacodynamic-disease progression (PK/PD/DIS) model was developed to characterize the effects of anakinra in…

webdev2011年12月1日

Publication

Model-based Meta-analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

High development cost, low development success, cost-disciplined health-care policies, and intense competition demand an efficient…

webdev2011年12月1日

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モデルに基づく医薬品開発

Effects of Omeprazole and Genetic Polymorphism of CYP2C19 on the Clopidogrel Active Metabolite

Application of PBPK Modeling in Drug Discovery and Development at Pfizer

γ-hydroxybutyrate Blood/Plasma Partitioning: Effect of Physiologic pH on Transport by Monocarboxylate Transporters

ST Analysis of the Fetal Electrocardiogram in Intrapartum Fetal Monitoring: A Meta-analysis

Exposure-response Relationship of AMG 386 in Combination with Weekly Paclitaxel in Recurrent Ovarian Cancer and Its Implication for Dose Selection

Pre-clinical Metabolism and Disposition of SB939 (Pracinostat), an Orally Active Histone Deacetylase Inhibitor, and Prediction of Human Pharmacokinetics

Influence of Mild and Moderate Hepatic Impairment on Axitinib Pharmacokinetics

Effect of Microgravity on the Pharmacokinetics of Ibuprofen in Humans

Population Pharmacokinetic-pharmacodynamic-disease Progression Model for Effects of Anakinra in Lewis Rats with Collagen-induced Arthritis

Model-based Meta-analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

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