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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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Value-focused Drug Development Strategies of the Future

Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.

Author(s): Craig Rayner
Solution: Clinical Pharmacology Strategy, Drug Development & Regulatory Strategy
Publication: Australasian BioTechnology
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