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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: broschard th. 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. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
Alternative (non-animal) methods for cosmetics testing: current status and future prospects-2010.
Adler S, Basketter D, Creton S, Pelkonen O, van Benthem J, Zuang V, Andersen KE, Angers-Loustau A, Aptula A, Bal-Price A, Benfenati E, Bernauer U, Bessems J, Bois FY, Boobis A, Brandon E, Bremer S, Broschard T, Casati S, Coecke S, Corvi R, Cronin M, Daston G, Dekant W, Felter S, Grignard E, Gundert-Remy U, Heinonen T, Kimber I, Kleinjans J, Komulainen H, Kreiling R, Kreysa J, Leite SB, Loizou G, Maxwell G, Mazzatorta P, Munn S, Pfuhler S, Phrakonkham P, Piersma A, Poth A, Prieto P, Repetto G, Rogiers V, Schoeters G, Schwarz M, Serafimova R, Tähti H, Testai E, van Delft J, van Loveren H, Vinken M, Worth A, Zaldivar JM. Adler S, et al. Arch Toxicol. 2011 May;85(5):367-485. doi: 10.1007/s00204-011-0693-2. Epub 2011 May 1. Arch Toxicol. 2011. PMID: 21533817 Review.
Safety evaluation of calcium L-methylfolate.
Niederberger KE, Dahms I, Broschard TH, Boehni R, Moser R. Niederberger KE, et al. Among authors: broschard th. Toxicol Rep. 2019 Sep 26;6:1018-1030. doi: 10.1016/j.toxrep.2019.09.012. eCollection 2019. Toxicol Rep. 2019. PMID: 31673504 Free PMC article.
21 results