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Physiologically-based Modeling Supports Drug Development Decisions, Regulatory Interactions and Drug Labeling

Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory life cycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a […]

Solution: PBPK Modeling & Simulation
Therapeutic Area: Cardiovascular, Infectious Disease, Oncology/Hematology, Pediatrics
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Drug Development and Label Optimization Using Proven Modeling and Simulation Methodology

The approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars. […]

Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Getting at the HAART of Precision Dosing: Using PBPK Models to Optimize Dosing of an Antiviral

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction […]

Speaker(s): Manoranjenni Chetty
Solution: Model-informed Drug Development, PBPK Modeling & Simulation
Therapeutic Area: Infectious Disease
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