Model Informed Drug Development Archives

Publication

Vaccination Mitigates the Impact of PRRSv Infection on the Pharmacokinetics of Ceftiofur Crystalline-free Acid in Pigs

The pharmacokinetics of intramuscularly administered ceftiofur crystalline-free acid (CCFA) were determined in pigs that were…

Certara2016年11月24日

Publication

Early Assessment of Proarrhythmic Risk of Drugs Using the In Vitro Data and Single-cell-based In Silico Models: Proof of Concept

Certara2016年11月23日

Publication

A Study to Examine the Relationship Between Metritis Severity and Depletion of Oxytetracycline in Plasma and Milk after Intrauterine Infusion

Metritis is a frequent problem in postpartum dairy cows. Intrauterine therapy with the antimicrobial oxytetracycline…

Certara2016年10月1日

Publication

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…

Certara2016年7月12日

Publication

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs.…

Certara2016年7月9日

Publication

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…

Certara2016年7月1日

Publication

Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis

The objective of this study was to assess the relationship between short-term and long-term treatment…

Certara2016年7月1日

Publication

Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients…

Certara2016年7月1日

Publication

Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process

Certara2016年6月16日

Publication

Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment

Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication…

Certara2016年6月11日

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モデルに基づく医薬品開発

Vaccination Mitigates the Impact of PRRSv Infection on the Pharmacokinetics of Ceftiofur Crystalline-free Acid in Pigs

Early Assessment of Proarrhythmic Risk of Drugs Using the In Vitro Data and Single-cell-based In Silico Models: Proof of Concept

A Study to Examine the Relationship Between Metritis Severity and Depletion of Oxytetracycline in Plasma and Milk after Intrauterine Infusion

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis

Potential Sources of Inter-subject Variability in Monoclonal Antibody Pharmacokinetics

Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process

Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment

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