Model Informed Drug Development Archives

Publication

Altered Plasma Pharmacokinetics of Ceftiofur Hydrochloride in Cows Affected with Severe Clinical Mastitis

Mastitis is a frequent problem among dairy cows, reducing milk yield and increasing cull rates.…

webdev2016 年 1 月 1 日

Publication

Population PK & Dosing Implications for Cobimetinib in Cancer Patients

A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact…

webdev2015 年 11 月 1 日

Publication

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

Bioavailability of orally administered drugs can be influenced by a number of factors including release…

webdev2015 年 11 月 1 日

Publication

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

Tramadol is frequently used in geriatric patients; however, pharmacokinetic (PK) publications on tramadol and O-desmethyltramadol…

webdev2015 年 10 月 27 日

Publication

Development of a Multicompartment Permeability-limited Lung PBPK Model and Its Application in Predicting Pulmonary Pharmacokinetics of Antituberculosis Drugs

Achieving sufficient concentrations of antituberculosis (TB) drugs in pulmonary tissue at the optimum time is still a challenge in…

webdev2015 年 10 月 1 日

Publication

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

The published OS model and resultant simulations can be leveraged to support Phase II design…

webdev2015 年 9 月 1 日

Publication

Are Physiologically-based Pharmacokinetic Models Reporting the Right Cmax? Central Venous Versus Peripheral Sampling Site

Physiologically based pharmacokinetic (PBPK) models can over-predict maximum plasma concentrations (Cmax) following intravenous administration. A proposed explanation is that invariably…

webdev2015 年 9 月 1 日

Publication

Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients

Motesanib is a small molecule and potent multikinase inhibitor with antiangiogenic and antitumor activity. Population…

webdev2015 年 7 月 23 日

Publication

Application of an LC-MS/MS Method for the Simultaneous Quantification of Human Intestinal Transporter Proteins Absolute Abundance Using a QconCAT Technique

Transporter proteins expressed in the gastrointestinal tract play a major role in the oral absorption of some…

webdev2015 年 6 月 10 日

Publication

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal…

webdev2015 年 5 月 1 日

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模型引导的药物开发

Altered Plasma Pharmacokinetics of Ceftiofur Hydrochloride in Cows Affected with Severe Clinical Mastitis

Population PK & Dosing Implications for Cobimetinib in Cancer Patients

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

Development of a Multicompartment Permeability-limited Lung PBPK Model and Its Application in Predicting Pulmonary Pharmacokinetics of Antituberculosis Drugs

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

Are Physiologically-based Pharmacokinetic Models Reporting the Right Cmax? Central Venous Versus Peripheral Sampling Site

Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients

Application of an LC-MS/MS Method for the Simultaneous Quantification of Human Intestinal Transporter Proteins Absolute Abundance Using a QconCAT Technique

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

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