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New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.
Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ. Huang SM, et al. Among authors: temple r. J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. J Clin Pharmacol. 2008. PMID: 18378963 Review.
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: temple rj. 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.
New FDA regulation to improve safety reporting in clinical trials.
Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ. Sherman RB, et al. N Engl J Med. 2011 Jul 7;365(1):3-5. doi: 10.1056/NEJMp1103464. Epub 2011 Jun 8. N Engl J Med. 2011. PMID: 21651388 Free article. No abstract available.
329 results