Genotoxic and Elemental Impurities Network on LinkedIn: Deriving acceptable limits for non-mutagenic impurities in medicinal…

Genotoxic and Elemental Impurities Network’s Post

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Research Fellow in Drug Safety Toxicology Impurity Risk Management at Pfizer

8mo

For the latest analysis of toxicology data supporting durational qualification limits for non-mutagenic impurities take a look at this most recent manuscript. Thank you to the great group of authors on the EFPIA workgroup that contributed to this: Jim Harvey, Matt Martin, Elizabeth Martin, Teresa Wegesser, PhD, DABT, Dr. Susanne Brandstetter and Nigel Greene! https://lnkd.in/gNAemGUq

Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments

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Toxicologist, Impurities & Registrations, Chemical & Preclinical Safety, Merck Healthcare KGaA, Darmstadt, Germany

7mo

Thanks for sharing this great publication! Congratulations to all authors. 👏🏻

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