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.
Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology
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.
Certara Experts Highlight Quantitative Systems Pharmacology’s Role in First-in-human Clinical Trials
PRINCETON, NJ – July 26, 2018 – Certara announced today that Clinical Pharmacology & Therapeutics has published its “Letter to the Editor” describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency’s response.
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.
David Lowis described a case study where D360 was used to replace older technologies at a biotechnology company. He also showed D360’s new visualization tools and shares the future roadmap as D360 advances its support of biologics in addition to small molecules.
Certara Acquires Analytica Laser, a Leader in Market Access, Health Economics and Outcomes Research (HEOR), and Real-world Evidence Solutions
PRINCETON, NJ – Apr. 12, 2018 – Certara today announced that it has acquired Analytica Laser, a global research consultancy that uses health economics and outcomes research (HEOR) and real-world data to provide the highest level of scientific evidence of the value of medicines and health technologies.
Quantitative Analysis of Gentamicin Exposure in Neonates and Infants Calls into Question Its Current Dosing Recommendations
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]