Model Informed Drug Development Archives

Publication

Determination of a Quantitative Relationship Between Hepatic CYP3A51/3 and CYP3A4 Expression for Use in the Prediction of Metabolic Clearance in Virtual Populations

The creation of virtual populations allows the estimation of pharmacokinetic parameters, such as metabolic clearance…

webdev2010 年 11 月 1 日

Publication

Incorporating Human Dosimetry and Exposure into High-throughput In Vitro Toxicity Screening

Many chemicals in commerce today have undergone limited or no safety testing. To reduce the…

webdev2010 年 10 月 1 日

Publication

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

γ-Hydroxybutyric acid (GHB), a drug of abuse, exhibits saturable renal clearance and capacity-limited metabolism. The …

webdev2010 年 9 月 1 日

Publication

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

Pharmacokinetic-pharmacodynamic relationships are crucial in understanding a drug's arrhythmogenic potential. Models assist to quantitatively relate…

webdev2010 年 8 月 21 日

Publication

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

webdev2010 年 7 月 13 日

Publication

Confidence Assessment of Predicting Clinical Drug Interactions of Mechanism-based CYP3A Inhibitors Using Simcyp Time-based Approach and a Static Mathematic Model

Accurate prediction of the extent of mechanism-based CYP3A inhibition is critical in determining the timing…

webdev2010 年 7 月 1 日

Publication

Relationship Between Exposure to Sunitinib and Efficacy and Tolerability Endpoints in Patients with Cancer: Results of a Pharmacokinetic/Pharmacodynamic Meta-analysis

In this pharmacokinetic/pharmacodynamic meta-analysis, we investigated relationships between clinical endpoints and sunitinib exposure in patients…

webdev2010 年 7 月 1 日

Publication

Selection of Alternative CYP3A4 Probe Substrates for Clinical Drug Interaction Studies Using In Vitro Data and In Vivo Simulation

Understanding the potential for cytochrome P450-mediated drug-drug interactions (DDIs) is a critical step in the drug discovery process. DDIs…

webdev2010 年 6 月 1 日

Publication

Concentration–Effect Relationships for the Drug of Abuse—γ-hydroxybutyric Acid

γ-Hydroxybutyric acid (GHB) is an endogenous neurotransmitter that is abused because of its sedative/hypnotic and…

webdev2010 年 6 月 1 日

Publication

Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis

Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium…

webdev2010 年 6 月 1 日

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模型引导的药物开发

Determination of a Quantitative Relationship Between Hepatic CYP3A51/3 and CYP3A4 Expression for Use in the Prediction of Metabolic Clearance in Virtual Populations

Incorporating Human Dosimetry and Exposure into High-throughput In Vitro Toxicity Screening

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

Confidence Assessment of Predicting Clinical Drug Interactions of Mechanism-based CYP3A Inhibitors Using Simcyp Time-based Approach and a Static Mathematic Model

Relationship Between Exposure to Sunitinib and Efficacy and Tolerability Endpoints in Patients with Cancer: Results of a Pharmacokinetic/Pharmacodynamic Meta-analysis

Selection of Alternative CYP3A4 Probe Substrates for Clinical Drug Interaction Studies Using In Vitro Data and In Vivo Simulation

Concentration–Effect Relationships for the Drug of Abuse—γ-hydroxybutyric Acid

Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis

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