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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: troth s. Toxicol Pathol. 2024 Feb;52(2-3):138-148. doi: 10.1177/01926233241248654. Epub 2024 Jun 6. Toxicol Pathol. 2024. PMID: 38840532 Review.
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Sistare FD, et al. Among authors: troth s. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
37 results