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Regulatory Toxicology and Pharmacology : RTP|May 22, 2013
Potentially mutagenic impurities: analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impuritiesSheila M Galloway, M Vijayaraj Reddy, Katherine McGettigan, et al.
Regulatory Toxicology and Pharmacology : RTP|May 18, 2024
Analysis of non-mutagenic substances in the context of drug impurity assessment - Few are potent toxicantsCatrin Hasselgren, Michelle Kenyon, Lennart T Anger, et al.
International Journal of Toxicology|February 14, 2025
I Wish I Had Known That! Impactful Guidance and Perspectives for a Fulfilling Career in ToxicologyJessica C Graham, Joel Bercu, Marie C Fortin, et al.
The Annals of Occupational Hygiene|June 25, 2014
Bioavailability of therapeutic proteins by inhalation--worker safety aspectsThomas Pfister, David Dolan, Joel Bercu, et al.
Regulatory Toxicology and Pharmacology : RTP|September 26, 2024
N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 DaJoel Bercu, Olivier Dirat, Krista Dobo, et al.
Regulatory Toxicology and Pharmacology : RTP|July 11, 2022
The utility of hERG channel inhibition data in the derivation of occupational exposure limitsJillian A Parker, Ernest S Fung, Alejandra Trejo-Martin, et al.
Regulatory Toxicology and Pharmacology : RTP|October 15, 2020
Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updatesCatrin Hasselgren, Joel Bercu, Alex Cayley, et al.
Chemical Research in Toxicology|May 9, 2022
An Evaluation of the Occupational Health Hazards of Peptide CouplersJessica C Graham, Alejandra Trejo-Martin, Martyn L Chilton, et al.
Regulatory Toxicology and Pharmacology : RTP|September 25, 2023
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)Melisa Masuda-Herrera, Hannah T Rosen, Anders Burild, et al.
Regulatory Toxicology and Pharmacology : RTP|September 7, 2024
Safety assessment of protein A and derivation of a parenteral health-based exposure limitJessica C Graham, Sathanandam S Anand, Joel Bercu, et al.
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