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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: farrelly jg. Toxicol Lett. 2000 Jan 5;111(3):199-202. doi: 10.1016/s0378-4274(99)00152-6. Toxicol Lett. 2000. PMID: 10643863
Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans.
Choudary J, Contrera JF, DeFelice A, DeGeorge JJ, Farrelly JG, Fitzgerald G, Goheer MA, Jacobs A, Jordan A, Meyers L, Osterberg R, Resnick C, Sun CJ, Temple RJ. Choudary J, et al. Among authors: farrelly jg. Clin Pharmacol Ther. 1996 Mar;59(3):265-7. doi: 10.1016/S0009-9236(96)80003-8. Clin Pharmacol Ther. 1996. PMID: 8653988 No abstract available.
CDER photosafety guidance for industry.
Jacobs AC, Brown PC, Chen C, Ellis A, Farrelly J, Osterberg R. Jacobs AC, et al. Toxicol Pathol. 2004 Jul-Aug;32 Suppl 2:17-8. doi: 10.1080/01926230490463821. Toxicol Pathol. 2004. PMID: 15503660
38 results