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Page 1
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: stanard b. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
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: stanard b. 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
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: stanard b. 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.
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: stanard b. 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
Introduction of a process mass intensity metric for biologics.
Budzinski K, Blewis M, Dahlin P, D'Aquila D, Esparza J, Gavin J, Ho SV, Hutchens C, Kahn D, Koenig SG, Kottmeier R, Millard J, Snyder M, Stanard B, Sun L. Budzinski K, et al. Among authors: stanard b. N Biotechnol. 2019 Mar 25;49:37-42. doi: 10.1016/j.nbt.2018.07.005. Epub 2018 Aug 16. N Biotechnol. 2019. PMID: 30121383