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Managing Immunogenicity Using Quantitative Systems Pharmacology

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.

Author(s): Piet van der Graaf, Andrzej Kierzek, Timothy Hickling
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Cardiovascular, Central Nervous System, Dermatology, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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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.

Speaker(s): Pau Aceves
Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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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.

Solution: Systems Pharmacology
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Real Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment

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.

Speaker(s): Mark Holbrook, Nikunj Patel, Sebastian Polak
Solution: PBPK Modeling & Simulation
Therapeutic Area: Central Nervous System
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Using a Pharmacology to Payer Framework to Support Product Development

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, […]

Author(s): Carl Kirkpatrick, Craig Rayner
Solution: Clinical Pharmacology Strategy
Therapeutic Area: Infectious Disease
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