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Regulatory Toxicology and Pharmacology : RTP|August 7, 2021
Calculating qualified non-mutagenic impurity levels: Harmonization of approachesJessica C Graham, Mark W Powley, Erika Udovic, et al.
Biotechnology and Bioengineering|January 10, 2026
Assessment and Control of Host Cell Proteins in Biologics: Survey of Industry Practices and a Vision for HarmonizationJessica Graham, Sathanandam S Anand, Joel Bercu, et al.
Critical Reviews in Toxicology|June 15, 2022
Framework for sensitization assessment of extractables and leachables in pharmaceuticalsPatricia Parris, Geraldine Whelan, Anders Burild, et al.
Regulatory Toxicology and Pharmacology : RTP|August 14, 2022
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acidsRobert A Jolly, Suren Bandara, Joel Bercu, et al.
Mutagenesis|February 14, 2026
Nitrosamine Ames Data Review and Method Development: Proceedings of a US FDA/HESI WorkshopAisar Atrakchi, Raechel Puglisi, Joel Bercu, et al.
PDA Journal of Pharmaceutical Science and Technology|September 15, 2023
Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database AnalysisPatricia Parris, Geraldine Whelan, Anders Burild, et al.
Regulatory Toxicology and Pharmacology : RTP|October 10, 2020
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studiesPatricia Parris, Elizabeth A Martin, Brad Stanard, et al.
Regulatory Toxicology and Pharmacology : RTP|December 19, 2020
A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labellingJoel Bercu, Melisa J Masuda-Herrera, Alejandra Trejo-Martin, et al.
Mutagenesis|September 7, 2018
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?Alexander Amberg, Lennart T Anger, Joel Bercu, et al.
Regulatory Toxicology and Pharmacology : RTP|January 30, 2025
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug productsPatricia Parris, Geraldine Whelan, Martyn L Chilton, et al.
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