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Similar articles for PMID: 35031541

107 results

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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. 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
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. 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.
107 results