Model Informed Drug Development Archives

Publication

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…

Certara2014年1月15日

論文

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…

Certara2014年1月1日

Publication

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Shedding of a pharmacological target from cells, giving rise to a soluble target that can also bind therapeutic proteins, is…

Certara2014年1月1日

Publication

Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling

Pregnancy is associated with considerable changes in the physiological, anatomical and biochemical attributes in women.…

Certara2013年12月13日

Publication

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to…

Certara2013年12月1日

Publication

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary…

Certara2013年12月1日

Publication

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

In environments where complete mechanistic knowledge of the system dynamics is not available, a synergy…

Certara2013年12月1日

Publication

Differences in Cytochrome P450-mediated Pharmacokinetics Between Chinese and Caucasian Populations Predicted by Mechanistic Physiologically-based Pharmacokinetic Modeling

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)…

Certara2013年12月1日

Publication

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel

Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined…

Certara2013年11月24日

On-Demand Webinar

Phoenix WinNonlin：A State of the Art Software Tool for Pre-clinical PK and TK Analysis

Are you currently using Excel for PK/TK analysis? Phoenix WinNonlin streamlines analyses and generates all…

Certara2013年11月21日

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モデルに基づく医薬品開発

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies

Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

Differences in Cytochrome P450-mediated Pharmacokinetics Between Chinese and Caucasian Populations Predicted by Mechanistic Physiologically-based Pharmacokinetic Modeling

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel

Phoenix WinNonlin：A State of the Art Software Tool for Pre-clinical PK and TK Analysis

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