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Page 1
Guide for Combining Primary Tumors for Statistical Analysis in Rodent Carcinogenicity Studies.
Keenan C, Al-Haddawi M, Bienvenu JG, Bradley AE, Brown P, Chen H, Colman K, Elwell M, Gatto N, Goodman D, Jacob B, Lanning L, McKinney L, Muhlbradt E, Perry R, Piaia A, Potenta D, Regan KS, Sefing B, Thibodeau M, Tibbs-Slone E, Woicke J, Zwickl CM. Keenan C, et al. Among authors: colman k. Toxicol Pathol. 2024 Jan;52(1):13-20. doi: 10.1177/01926233241230553. Epub 2024 Mar 6. Toxicol Pathol. 2024. PMID: 38445634
An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.
Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurström S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ. Sistare FD, et al. Among authors: colman k. Toxicol Pathol. 2011 Jun;39(4):716-44. doi: 10.1177/0192623311406935. Toxicol Pathol. 2011. PMID: 21666103
Nonproliferative and proliferative lesions of the rat and mouse female reproductive system.
Dixon D, Alison R, Bach U, Colman K, Foley GL, Harleman JH, Haworth R, Herbert R, Heuser A, Long G, Mirsky M, Regan K, Van Esch E, Westwood FR, Vidal J, Yoshida M. Dixon D, et al. Among authors: colman k. J Toxicol Pathol. 2014;27(3-4 Suppl):1S-107S. doi: 10.1293/tox.27.1S. J Toxicol Pathol. 2014. PMID: 25516636 Free PMC article. Review.
International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Nonproliferative and Proliferative Lesions of the Dog.
Woicke J, Al-Haddawi MM, Bienvenu JG, Caverly Rae JM, Chanut FJ, Colman K, Cullen JM, Davis W, Fukuda R, Huisinga M, Walker UJ, Kai K, Kovi RC, Macri NP, Marxfeld HA, Nikula KJ, Pardo ID, Rosol TJ, Sharma AK, Singh BP, Tamura K, Thibodeau MS, Vezzali E, Vidal JD, Meseck EK. Woicke J, et al. Among authors: colman k. Toxicol Pathol. 2021 Jan;49(1):5-109. doi: 10.1177/0192623320968181. Toxicol Pathol. 2021. PMID: 33393871
BSTP Review of 12 Case Studies Discussing the Challenges, Pathology, Immunogenicity, and Mechanisms of Inhaled Biologics.
Hall AP, Tepper JS, Boyle MH, Cary MG, Flandre TG, Piaia A, Tarnow I, Macri NP, Freke MC, Nikula KJ, Paul GR, Cauvin A, Gregori M, Haworth R, Naylor S, Price M, Robinson IN, Allen A, Gelzleichter T, Hohlbaum AM, Manetz S, Wolfreys A, Colman K, Fleurance R, Jones D, Mukaratirwa S. Hall AP, et al. Among authors: colman k. Toxicol Pathol. 2021 Feb;49(2):235-260. doi: 10.1177/0192623320976094. Epub 2021 Jan 18. Toxicol Pathol. 2021. PMID: 33455525 Review.
Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies.
Vidal JD, Colman K, Bhaskaran M, de Rijk E, Fegley D, Halpern W, Jacob B, Kandori H, Manickam B, McKeag S, Parker GA, Regan KS, Sefing B, Thibodeau M, Vemireddi V, Werner J, Zalewska A. Vidal JD, et al. Among authors: colman k. Toxicol Pathol. 2021 Jul;49(5):977-989. doi: 10.1177/0192623321990631. Epub 2021 Mar 4. Toxicol Pathol. 2021. PMID: 33661059 Review.
International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Non-proliferative and Proliferative Lesions of the Non-human Primate (M. fascicularis).
Colman K, Andrews RN, Atkins H, Boulineau T, Bradley A, Braendli-Baiocco A, Capobianco R, Caudell D, Cline M, Doi T, Ernst R, van Esch E, Everitt J, Fant P, Gruebbel MM, Mecklenburg L, Miller AD, Nikula KJ, Satake S, Schwartz J, Sharma A, Shimoi A, Sobry C, Taylor I, Vemireddi V, Vidal J, Wood C, Vahle JL. Colman K, et al. J Toxicol Pathol. 2021;34(3 Suppl):1S-182S. doi: 10.1293/tox.34.1S. Epub 2021 Sep 28. J Toxicol Pathol. 2021. PMID: 34712008 Free PMC article. Review.
Scientific and Regulatory Policy Committee Best Practices: Recommended ("Best") Practices for Informed (Non-blinded) Versus Masked (Blinded) Microscopic Evaluation in Animal Toxicity Studies.
Bolon B, Francke S, Caverly Rae JM, Polack E, Regan KS, McInnes EF, Young JK, Keane K, Perry R, Romeike A, Colman K, Jensen K, Nakano-Ito K, Galbreath EJ. Bolon B, et al. Among authors: colman k. Toxicol Pathol. 2022 Dec;50(8):930-941. doi: 10.1177/01926233221135563. Epub 2022 Nov 14. Toxicol Pathol. 2022. PMID: 36377245
Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies.
McDorman KS, Bennet BM, Colman K, Fikes JD, Keirstead ND, Lanning Retired L, Munch B, Romeike A, Schafer KA, Schorsch F, Thibodeau MS, Thomas HC, Troth S, Vahle JL, Geoly FJ. McDorman KS, et al. Among authors: colman k. Toxicol Pathol. 2024 Feb;52(2-3):138-148. doi: 10.1177/01926233241248654. Epub 2024 Jun 6. Toxicol Pathol. 2024. PMID: 38840532 Review.
54 results