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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: masuda herrera m. 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.
Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides.
Bercu JP, Galloway SM, Parris P, Teasdale A, Masuda-Herrera M, Dobo K, Heard P, Kenyon M, Nicolette J, Vock E, Ku W, Harvey J, White A, Glowienke S, Martin EA, Custer L, Jolly RA, Thybaud V. Bercu JP, et al. Regul Toxicol Pharmacol. 2018 Apr;94:172-182. doi: 10.1016/j.yrtph.2018.02.001. Epub 2018 Feb 9. Regul Toxicol Pharmacol. 2018. PMID: 29408293
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. 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. Among authors: masuda herrera m. Regul Toxicol Pharmacol. 2021 Nov;126:105023. doi: 10.1016/j.yrtph.2021.105023. Epub 2021 Aug 4. Regul Toxicol Pharmacol. 2021. PMID: 34363920
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: masuda herrera mj. 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: masuda herrera m. Regul Toxicol Pharmacol. 2022 Oct;134:105242. doi: 10.1016/j.yrtph.2022.105242. Epub 2022 Aug 11. Regul Toxicol Pharmacol. 2022. PMID: 35964842
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).
Bercu JP, Masuda-Herrera M, Trejo-Martin A, Sura P, Jolly R, Kenyon M, Thomas R, Ponting DJ, Snodin D, Tuschl G, Simon S, De Vlieger K, Hutchinson R, Czich A, Glowienke S, Reddy MV, Johanssen S, Vock E, Claude N, Weaver RJ. Bercu JP, et al. Among authors: masuda herrera m. Regul Toxicol Pharmacol. 2023 Aug;142:105415. doi: 10.1016/j.yrtph.2023.105415. Epub 2023 May 29. Regul Toxicol Pharmacol. 2023. PMID: 37257751 Free article.
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: masuda herrera m. PDA J Pharm Sci Technol. 2023 Sep 15:pdajpst.2022.012811. doi: 10.5731/pdajpst.2022.012811. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37714567
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.
Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
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