David G. Dolan

David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.

Articles

Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation

David G. Dolan;Ester Lovsin Barle;Markus Schwind;Camille Jandard;Gregor Tuschl;Claudia Sehner

May 2nd 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.

Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II

Andreas Flueckiger;Michel Crevoisier;David G. Dolan;Ester Lovsin Barle;

August 2nd 2016

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Cleaning Limits—Why the 10-ppm Criterion should be Abandoned

Allan Ader;Andreas Flueckiger;Michel Crevoisier;David G. Dolan;Ester Lovsin Barle;

January 2nd 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.