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Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.

Solution: PBPK Modeling & Simulation
Therapeutic Area: Dermatology
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Certara Scientists Advance ASCPT Agenda: From Molecule to Patient

PRINCETON, NJ – Mar. 13, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 […]

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