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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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Model Firsts

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.

Author(s): Karen Tkach Tuzman
Solution: Systems Pharmacology
Publication: BioCentury Innovations
Therapeutic Area: Central Nervous System
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The Modernization of Orphan Drug Development

Orphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.

Author(s): Maria Saluta
Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Pediatrics, Rare/Orphan Disease
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Predictive Toxicology: Bringing Chemical Risk Assessment into the 21st Century

Traditional toxicology methods, using in vivo animal testing, is an unrealistic approach to predict chemical risk assessment. Mechanistic modeling and simulation tools such as PBPK and QST can expedite toxicological screening, support the prioritization for testing compounds that merit greater study, and reduce unnecessary animal testing.

Author(s): Maria Saluta
Solution: PBPK Modeling & Simulation
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The Use of Model-informed Precision Dosing to Improve Patient Drug Treatment Outcomes

Precision dosing is a crucial cornerstone of precision medicine that will provide patients the most efficacious medications with minimum probability of adverse events. Model-informed precision dosing, using quantitative modeling and simulation approaches, such as PBPK and NLME, can improve precision dosing in clinical care.

Author(s): Maria Saluta
Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation
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