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Regulatory science: a special update from the United States Food and Drug Administration: Preclinical issues and status of investigation of botanical drug products in the United States.
Wu KM, DeGeorge JG, Atrakchi A, Barry E, Bigger A, Chen C, Du T, Freed L, Geyer H, Goheer A, Jacobs A, Jean D, Rhee H, Osterberg R, Schmidt W, Farrelly JG. Wu KM, et al. Among authors: atrakchi a. Toxicol Lett. 2000 Jan 5;111(3):199-202. doi: 10.1016/s0378-4274(99)00152-6. Toxicol Lett. 2000. PMID: 10643863
Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug-related metabolite, or drug-related impurity.
Robison TW, Heflich RH, Manjanatha MG, Elespuru R, Atrakchi A, Mei N, Ding W. Robison TW, et al. Among authors: atrakchi a. Mutat Res Genet Toxicol Environ Mutagen. 2021 Aug-Sep;868-869:503386. doi: 10.1016/j.mrgentox.2021.503386. Epub 2021 Jul 22. Mutat Res Genet Toxicol Environ Mutagen. 2021. PMID: 34454692
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