Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.
By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions.
In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook introduced the Cardiac Safety Simulator (CSS) platform and explained how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions.
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.
In this webinar, Dr. Tom Polasek, a clinical pharmacologist at Certara Strategic Consulting, explained how he used the Simcyp Simulator to predict olanzapine exposure in individual patients. By watching this webinar you will learn how PBPK modeling and simulation technology can be re-purposed to support model-informed precision dosing.
PRINCETON, NJ – Feb. 27, 2018 – Certara today announced that it has published two papers demonstrating proof of concept for its Virtual Twin™ technology.
