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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.
October 03, 2018
This article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
September 01, 2018
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
December 02, 2015
The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
September 02, 2015
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
March 02, 2015
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.