ARTICLE | Company News
Complex generic first to show ‘virtual’ bioequivalence with Certara’s modeling system
June 13, 2019 8:46 PM UTC
FDA's approval of an undisclosed complex generic via the ANDA pathway marks the first use of Certara's modeling systems, rather than clinical studies, to demonstrate bioequivalence.
The Simcyp Simulator, a physiologically based pharmacokinetic (PBPK) modeling and simulation platform, can demonstrate bioequivalence in silico, which Certara L.P. (Princeton, N.J.) said is safer, faster and less expensive than clinical trials...