The Wall Street Journal reports that FDA will be using simulations to try to identify safety and effectiveness problems in drugs under development. The simulation technology, developed by Entelos, will be used to test three drugs under investigation for heart-related conditions. "The agreement is part of a broader effort by the FDA to get an earlier read on the safety and efficacy of new drugs and to identify the characteristics of patients that lead some to benefit from a drug while others are at risk of a bad outcome," says the article.
Simulating for Safety
Dec 17, 2008