メインコンテンツにスキップ

Applications of Linking PBPK and PD Models to Predict the Impact of Genotypic Variability, Formulation Differences, Differences in Target Binding Capacity and Target Site Drug Concentrations on Drug Responses and Variability

This study aimed to demonstrate the added value of integrating prior in vitro data and knowledge-rich physiologically based pharmacokinetic (PBPK) models with pharmacodynamics (PDs) models. Four distinct applications that were developed and tested are presented here. PBPK models were developed for metoprolol using different CYP2D6 genotypes based on in vitro data. Application of the models for prediction of phenotypic differences in the pharmacokinetics (PKs) and PD compared … Continued

PK/PD Data Analysis Experts to Lead Advanced Model-based Drug Development Workshop

PRINCETON, NJ – Nov. 21, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that industry-renowned pharmacokinetic (PK) and pharmacodynamic (PD) modeling experts Drs. Daniel Weiner and Johan Gabrielsson will be leading an Advanced Level PK-PD Data Analysis Workshop in San Diego, CA from Feb. 17-20, 2015. The FDA … Continued

PBPK Is Ready for NDA- and IND-related Submissions! But Are YOU Ready for PBPK?

Recently, the US Food and Drug Administration held a workshop on “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection.” With the FDA’s intention to maintain an efficient review process for human drug and biological products, PBPK models may be useful for assessing risk during drug development. Indeed, PBPK models have increasingly been applied … Continued

Certara Updates its Simcyp Simulator Used to Predict Drug Behavior in Virtual Patient Populations

Simcyp Simulator advances drug development and regulatory approval for majority of top 40 pharma companies PRINCETON, NJ – Nov. 19, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that it has released version 14 of its Simcyp™ Population-based Simulator, which enables biopharmaceutical researchers to predict drug-drug interactions and … Continued

Certara Updates Its Industry-leading PK/PD Phoenix Platform and Introduces Phoenix Quantum

Release includes updates to Phoenix WinNonlin, the gold standard for pharmacokinetic and pharmacodynamic (PK/PD) modeling used in preclinical and clinical drug development PRINCETON, NJ – Nov. 3, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced the launch of version 1.4 of its Phoenix® product family at the American … Continued

1 of 2
Powered by Translations.com GlobalLink OneLink Software