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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: callis cm. Regul Toxicol Pharmacol. 2022 Oct;134:105242. doi: 10.1016/j.yrtph.2022.105242. Epub 2022 Aug 11. Regul Toxicol Pharmacol. 2022. PMID: 35964842
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: callis cm. 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
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. Among authors: callis cm. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429