Model Informed Drug Development Archives

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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…

Danielle Pillsbury2014 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…

Danielle Pillsbury2014 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.…

Danielle Pillsbury2013 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…

Danielle Pillsbury2013 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…

Danielle Pillsbury2013 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…

Danielle Pillsbury2013 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)…

Danielle Pillsbury2013 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…

Danielle Pillsbury2013 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…

Danielle Pillsbury2013 年 11 月 21 日

On-Demand Webinar

Introduction to Population PK/PD Analysis Using Phoenix NLME

Phoenix NLME provides sophisticated algorithms and powerful and flexible data processing and modeling tools for…

Danielle Pillsbury2013 年 11 月 14 日

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模型引导的药物开发

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

Introduction to Population PK/PD Analysis Using Phoenix NLME

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