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David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.
May 02, 2017
In 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.
August 02, 2016
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
January 02, 2016
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.