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Page 1
Principles and Procedures for Assessment of Acute Toxicity Incorporating In Silico Methods.
Zwickl CM, Graham J, Jolly R, Bassan A, Ahlberg E, Amberg A, Anger LT, Barton-Maclaren T, Beilke L, Bellion P, Brigo A, Cronin MTD, Custer L, Devlin A, Burleigh-Flayers H, Fish T, Glover K, Glowienke S, Gromek K, Jones D, Karmaus A, Kemper R, Piparo EL, Madia F, Martin M, Masuda-Herrera M, McAtee B, Mestre J, Milchak L, Moudgal C, Mumtaz M, Muster W, Neilson L, Patlewicz G, Paulino A, Roncaglioni A, Ruiz P, Suarez D, Szabo DT, Valentin JP, Vardakou I, Woolley D, Myatt G. Zwickl CM, et al. Among authors: graham j. Comput Toxicol. 2022 Nov;24:100237. doi: 10.1016/j.comtox.2022.100237. Epub 2022 Jul 14. Comput Toxicol. 2022. PMID: 36818760 Free PMC article.
A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.
Bercu J, Masuda-Herrera MJ, Trejo-Martin A, Hasselgren C, Lord J, Graham J, Schmitz M, Milchak L, Owens C, Lal SH, Robinson RM, Whalley S, Bellion P, Vuorinen A, Gromek K, Hawkins WA, van de Gevel I, Vriens K, Kemper R, Naven R, Ferrer P, Myatt GJ. Bercu J, et al. Among authors: graham j. Regul Toxicol Pharmacol. 2021 Mar;120:104843. doi: 10.1016/j.yrtph.2020.104843. Epub 2020 Dec 17. Regul Toxicol Pharmacol. 2021. PMID: 33340644 Free PMC article.
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches.
Graham JC, Powley MW, Udovic E, Glowienke S, Nicolette J, Parris P, Kenyon M, White A, Maisey A, Harvey J, Martin EA, Dowdy E, Masuda-Herrera M, Trejo-Martin A, Bercu J. Graham JC, et al. Regul Toxicol Pharmacol. 2021 Nov;126:105023. doi: 10.1016/j.yrtph.2021.105023. Epub 2021 Aug 4. Regul Toxicol Pharmacol. 2021. PMID: 34363920
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls).
Masuda-Herrera MJ, Bercu JP, Broschard TH, Burild A, Hasselgren C, Parris P, Ford LC, Graham J, Stanard B, Comerford M, Lettiere D, Erler S, Callis CM, Morinello E, Muster W, Martin EA, Griffin TR, Nagao L, Cruz M. Masuda-Herrera MJ, et al. Among authors: graham j. PDA J Pharm Sci Technol. 2022 Sep-Oct;76(5):369-383. doi: 10.5731/pdajpst.2021.012693. Epub 2022 Jan 14. PDA J Pharm Sci Technol. 2022. PMID: 35031541
Corrigendum to a cross-industry collaboration to assess if acute toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling. Regulatory toxicology and pharmacology (2021) 104843.
Bercu J, Masuda Herrera MJ, Trejo-Martin A, Hasselgren C, Lord J, Graham J, Schmitz M, Milchak L, Owens C, Lal SH, Robinson RM, Whalley S, Bellion P, Vuorinen A, Gromek K, Hawkins WA, Van de Gevel I, Vriens K, Kemper R, Naven R, Ferrer P, Myatt GJ. Bercu J, et al. Among authors: graham j. Regul Toxicol Pharmacol. 2022 Jun;131:105165. doi: 10.1016/j.yrtph.2022.105165. Epub 2022 Apr 23. Regul Toxicol Pharmacol. 2022. PMID: 35474000 Free PMC article. No abstract available.
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids.
Jolly RA, Bandara S, Bercu J, Callis CM, Dolan DG, Graham J, HaMai D, Barle EL, Maier A, Masuda-Herrera M, Moudgal C, Parker JA, Reichard J, Sandhu R, Fung ES. Jolly RA, et al. Among authors: graham j. Regul Toxicol Pharmacol. 2022 Oct;134:105242. doi: 10.1016/j.yrtph.2022.105242. Epub 2022 Aug 11. Regul Toxicol Pharmacol. 2022. PMID: 35964842
Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis.
Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Chilton ML, Graham J, Johann E, Johnson C, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Cruz MT, Nagao L. Parris P, et al. Among authors: graham j. PDA J Pharm Sci Technol. 2024 Aug 23;78(4):399-444. doi: 10.5731/pdajpst.2022.012811. PDA J Pharm Sci Technol. 2024. PMID: 37714567
Safety assessment of protein A and derivation of a parenteral health-based exposure limit.
Graham JC, Anand SS, Bercu J, Besenhofer L, de Zafra C, Feng Y, Fisher C, Hillegass J, Hutchinson R, Jolly R, Moudgal C, Nicholas T, Olszova D, Schmitz M, Semmelmann F. Graham JC, et al. Regul Toxicol Pharmacol. 2024 Nov;153:105700. doi: 10.1016/j.yrtph.2024.105700. Epub 2024 Sep 6. Regul Toxicol Pharmacol. 2024. PMID: 39243930 Free article.
5,325 results