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Submitting eCTD in Advance of a Milestone Application

While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We’ve heard this slogan since childhood. For those of you planning to implement eCTD, the early bird’s experience rings true. Many people erroneously believe that your first eCTD … Continued

Can QSP Save Lives? Lessons from the Bial Trial Debacle

One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.

Educating the World in Modeling and Simulation: Creating Certara University

“Fundamentally, Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions. Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first … Continued

Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand

It is essential to rapidly achieve therapeutic vancomycin concentrations in critically ill patients with gram-positive bacterial infections. This study aimed to determine optimal vancomycin dosing regimens for critically ill patients. Using an external dataset – therapeutic drug monitoring concentration data from 51 critically ill patients receiving vancomycin, we validated a population pharmacokinetic model to describe … Continued

A Six-stage Workflow for Robust Application of Systems Pharmacology

Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One factor critical to the ultimate success of QSP is the establishment of commonly accepted language, technical criteria, and workflows. We propose an integrated workflow that bridges conceptual objectives with underlying technical detail to support the execution, communication, and evaluation of … Continued

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