Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the … Continued
Month: October 2016
PRINCETON, NJ – Oct. 21, 2016 – Certara today announced it will be participating in 19 sessions at the Seventh American Conference on Pharmacometrics (ACoP7). This year’s conference is being held from Oct. 23-26 in Bellevue, Washington.
Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone … Continued
d3 Medicine challenges conventional dogmatic approaches and achieves unprecedented accelerated development pathways.
PRINCETON, NJ – Oct. 19, 2016 – Certara announces that the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA) has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp Population-based Simulator.