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Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies.
Palazzi X, Anger LT, Boulineau T, Grevot A, Guffroy M, Henson K, Hoepp N, Jacobsen M, Kale VP, Kreeger J, Lane JH, Li D, Muster W, Paisley B, Ramaiah L, Robertson N, Shultz V, Steger Hartmann T, Westhouse R. Palazzi X, et al. Among authors: ramaiah l. Regul Toxicol Pharmacol. 2024 Apr 27;150:105632. doi: 10.1016/j.yrtph.2024.105632. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 38679316
Effects of 2,3-DPG knockout on SCD phenotype in Townes SCD model mice.
Barakat A, Jasuja R, Tomlinson L, Wenzel Z, Ramaiah L, Petterson BA, Kapinos B, Sawant A, Pagan V, Lintner N, Field D, Ahn Y, Knee KM. Barakat A, et al. Among authors: ramaiah l. Am J Hematol. 2023 Dec;98(12):1838-1846. doi: 10.1002/ajh.27082. Epub 2023 Sep 9. Am J Hematol. 2023. PMID: 37688507
Considerations for the Identification and Conveyance of Clinical Pathology Findings in Preclinical Toxicity Studies: Results From the 9th ESTP International Expert Workshop.
Arndt T, Keresztes M, Olivier B, Boone L, Chanut F, Ennulat D, Evans E, Freyberger A, Johannes S, Kuper CF, Maliver P, O'Brien P, Ramaiah L, Roman I, Strauss V, Vinken P, Walker D, Winter M, Pohlmeyer-Esch G, Tomlinson L. Arndt T, et al. Among authors: ramaiah l. Toxicol Pathol. 2024 Apr 25:1926233241245108. doi: 10.1177/01926233241245108. Online ahead of print. Toxicol Pathol. 2024. PMID: 38661116
Translation of nonclinical to clinical safety findings for 27 biotherapeutics.
Leach MW, Rana P, Hu W, Mittapalli RK, Pinkstaff J, Potter D, Qiu XM, Ramaiah L, Rohde C, Xia F, Khan KN. Leach MW, et al. Among authors: ramaiah l. Toxicol Appl Pharmacol. 2024 Mar;484:116854. doi: 10.1016/j.taap.2024.116854. Epub 2024 Feb 10. Toxicol Appl Pharmacol. 2024. PMID: 38346540 Free article.
The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey.
Zabka TS, Burkhardt J, Reagan WJ, Gautier JC, Glaab WE, Guffroy M, Harding J, Brees D, McDuffie E, Ramaiah L, Schultze AE, Smith JD, Wolfreys A, Dalmas DA. Zabka TS, et al. Among authors: ramaiah l. Regul Toxicol Pharmacol. 2021 Mar;120:104857. doi: 10.1016/j.yrtph.2020.104857. Epub 2020 Dec 31. Regul Toxicol Pharmacol. 2021. PMID: 33387566 Free article.
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