Wu KM - Search Results

1

Regulatory toxicology perspectives on the development of botanical drug products in the United States.

Wu KM, Farrelly J, Birnkrant D, Chen S, Dou J, Atrakchi A, Bigger A, Chen C, Chen Z, Freed L, Ghantous H, Goheer A, Hausner E, Osterberg R, Rhee H, Zhang K. Wu KM, et al. Am J Ther. 2004 May-Jun;11(3):213-7. doi: 10.1097/00045391-200405000-00010. Am J Ther. 2004. PMID: 15133537 Review.

2

Preclinical development of new drugs that enhance thyroid hormone metabolism and clearance: inadequacy of using rats as an animal model for predicting human risks in an IND and NDA.

Wu KM, Farrelly JG. Wu KM, et al. Am J Ther. 2006 Mar-Apr;13(2):141-4. doi: 10.1097/01.mjt.0000209673.01885.b0. Am J Ther. 2006. PMID: 16645431 Review.

3

Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: nonclinical Pharm/Tox analysis and the role of comparative toxicology.

Wu KM, Farrelly JG. Wu KM, et al. Toxicology. 2007 Jul 1;236(1-2):1-6. doi: 10.1016/j.tox.2007.04.005. Epub 2007 Apr 21. Toxicology. 2007. PMID: 17507137

4

Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States.

Wu KM, Ghantous H, Birnkrant DB. Wu KM, et al. Food Chem Toxicol. 2008 Aug;46(8):2606-10. doi: 10.1016/j.fct.2008.05.029. Epub 2008 Jun 4. Food Chem Toxicol. 2008. PMID: 18614266 Review.

5

Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.

Wu KM, Dou J, Ghantous H, Chen S, Bigger A, Birnkrant D. Wu KM, et al. Regul Toxicol Pharmacol. 2010 Feb;56(1):1-3. doi: 10.1016/j.yrtph.2009.09.012. Epub 2009 Sep 24. Regul Toxicol Pharmacol. 2010. PMID: 19782117

6

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. Toxicol Lett. 2000 Jan 5;111(3):199-202. doi: 10.1016/s0378-4274(99)00152-6. Toxicol Lett. 2000. PMID: 10643863

7

Timing of carcinogenicity studies and predictability of genotoxicity for tumorigenicity in anti-HIV drug development.

Wu KM, Powley MW, Ghantous H. Wu KM, et al. Int J Toxicol. 2012 Jun;31(3):211-21. doi: 10.1177/1091581812439585. Epub 2012 May 1. Int J Toxicol. 2012. PMID: 22550047

8

New therapies from old medicines.

Chen ST, Dou J, Temple R, Agarwal R, Wu KM, Walker S. Chen ST, et al. Among authors: wu km. Nat Biotechnol. 2008 Oct;26(10):1077-83. doi: 10.1038/nbt1008-1077. Nat Biotechnol. 2008. PMID: 18846070 No abstract available.

9

Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development.

Wu KM, Farrelly JG, Upton R, Chen J. Wu KM, et al. Phytomedicine. 2007 Apr;14(4):273-9. doi: 10.1016/j.phymed.2006.05.009. Epub 2006 Jul 24. Phytomedicine. 2007. PMID: 16863692

10

A New Classification of Prodrugs: Regulatory Perspectives.

Wu KM. Wu KM. Pharmaceuticals (Basel). 2009 Oct 14;2(3):77-81. doi: 10.3390/ph2030077. Pharmaceuticals (Basel). 2009. PMID: 27713225 Free PMC article.

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