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.
PRINCETON, NJ – Oct. 13, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Peking Union Medical College (PUMC) Hospital in Beijing, China, and Keio University in Tokyo, Japan have become Phoenix Centers of Excellence.
Modeling and simulation in drug development could change the commercial and regulatory landscape forever… and can deliver significant business, scientific and clinical value to companies.
