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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.
Andrew Teasdale
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Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.
Articles by Andrew Teasdale
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.
The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Latest Updated Articles
Establishing Limits for Dermal Absorption of Elemental ImpuritiesSeptember 2nd 2015
EMA Guideline on Setting Health-Based Exposure LimitsDecember 2nd 2015
Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals TestsSeptember 1st 2018
- Retirement for Obsolete Heavy Metals Tests
October 3rd 2018
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