Changing the Game in Oncology Drug Development and Patient Access

Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

Modeling the Effects of Genetic Variation with Trial Simulator

Computer simulation provides an effective means for evaluating whether a clinical trial design is efficient and optimally informative with a high likelihood of success. Many variables affect the likelihood of success of a trial, and genetic variation in the population is being evaluated with increasing frequency for its impact on trial outcomes.

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Certara Launches CODEx to Inform Comparative Effectiveness and Drug Development Decisions

PRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Incorporating In Vitro Information on Drug Metabolism into Clinical Trial Simulations to Assess the Effect of CYP2D6 Polymorphisms on Pharmacokinetics and Pharmacodynamics: Dextromethorphan as a Model Application

In vitro-in vivo extrapolation of clearance, embedded in a clinical trial simulation, was used to investigate differences in the pharmacokinetics and pharmacodynamics of dextromethorphan between CYP2D6 poor and extensive metabolizer phenotypes. Information on the genetic variation of CYP2D6, as well as the in vitro metabolism and pharmacodynamics of dextromethorphan and its active metabolite dextrorphan, was … Continued

Pharmacokinetics of Vancomycin in Critically Ill Patients in Thailand

The pharmacokinetics and pharmacodynamics of drugs in critically ill patients are difficult to predict due to complex pathophysiological changes. Vancomycin is an antibiotic commonly used to treat serious gram positive bacterial infections in critically ill patients and the treatment goal is to rapidly achieve and maintain therapeutic concentrations. We assessed the pharmacokinetics of vancomycin in … Continued