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

How to Manage Pre-clinical Data as a Strategic Asset

A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, … 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

The Challenges of Determining Drug Dosing for Rare Diseases

Most people are familiar with the leading causes of morbidity and mortality in the United States—heart disease, cancer, and diabetes. However, did you know that an estimated 350 million people worldwide suffer from rare diseases? In this blog post, I’ll be discussing what constitutes a rare disease, how developing orphan drugs to treat rare diseases … Continued

PBPK Modeling and Simulation Discussed at the AAPS Annual Meeting

I recently got the chance to attend the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego, California. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. Pediatric drug development, in particular, remains a top challenge for the pharmaceutical industry as … 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