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Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than 10,000 children had been born with thalidomide-induced birth defects. “Phocomelia,” wherein babies were born with […]

Author(s): Rick Greupink
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Using Model-based Meta-analysis to Inform Drug Development for Autoimmune Diseases

MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Watch this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.

Speaker(s): Mark Lovern
Solution: Model-based Meta-analysis, PK/PD Modeling & Simulation
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Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development

Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]

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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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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The Biggest Drug Development News Stories in 2017

When I reflect on the state of drug development in 2017, the opening lines of Charles Dickens’ A Tale of Two Cities comes to mind. It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, […]

Author(s): Suzanne Minton
Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System, Oncology/Hematology
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