Gregor Tuschl, PhD is principal scientist, Early Non-Clinical Safety, Merck KgaA, Frankfurter Str. 250, U009/101, 64293 Darmstadt, Germany, gregor.tuschl@merckgroup.com.
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation
May 2nd 2017In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.