Certara’s Simcyp PBPK Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug
PRINCETON, NJ – 2019年6月12日 – 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.
