Complex generic first to show ‘virtual’ bioequivalence with Certara’s modeling system

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...