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Page 1
Framework for sensitization assessment of extractables and leachables in pharmaceuticals.
Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Graham J, Johann E, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Tien E, Cruz M, Nagao L. Parris P, et al. Among authors: masuda herrera m. Crit Rev Toxicol. 2022 Feb;52(2):125-138. doi: 10.1080/10408444.2022.2065966. Epub 2022 Jun 15. Crit Rev Toxicol. 2022. PMID: 35703156 Review.
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
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.
In Vivo Mutagenicity Testing of Arylboronic Acids and Esters.
Masuda-Herrera MJ, Dobo KL, Kenyon MO, Kenny JD, Galloway SM, Escobar PA, Reddy MV, Jolly RA, Trejo-Martin A, Brown C, Mckeon M, Young M, Bruce S, Pant K, Dutta A, Kulkarni R, Bercu JP. Masuda-Herrera MJ, et al. Environ Mol Mutagen. 2019 Dec;60(9):766-777. doi: 10.1002/em.22320. Epub 2019 Aug 17. Environ Mol Mutagen. 2019. PMID: 31335992
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.
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
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. 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
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
14 results