Temple RJ - Search Results

1

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.

Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I. Laughren TP, et al. Among authors: temple rj. J Clin Psychiatry. 2011 Sep;72(9):1166-73. doi: 10.4088/JCP.11r06984. J Clin Psychiatry. 2011. PMID: 21951984 Review.

2

Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials.

Merkatz RB, Temple R, Subel S, Feiden K, Kessler DA. Merkatz RB, et al. N Engl J Med. 1993 Jul 22;329(4):292-6. doi: 10.1056/NEJM199307223290429. N Engl J Med. 1993. PMID: 8305004 Free article. No abstract available.

3

The clinical pharmacologist in drug regulation: the US perspective.

Temple RJ. Temple RJ. Br J Clin Pharmacol. 1996 Jul;42(1):73-9. Br J Clin Pharmacol. 1996. PMID: 8807147 Free article.

4

Assessing tumor-related signs and symptoms to support cancer drug approval.

Williams G, Pazdur R, Temple R. Williams G, et al. J Biopharm Stat. 2004 Feb;14(1):5-21. doi: 10.1081/BIP-120028503. J Biopharm Stat. 2004. PMID: 15027497 Review.

5

BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective.

Temple R, Stockbridge NL. Temple R, et al. Ann Intern Med. 2007 Jan 2;146(1):57-62. doi: 10.7326/0003-4819-146-1-200701020-00010. Ann Intern Med. 2007. PMID: 17200223 Free article.

6

Drug interaction studies: study design, data analysis, and implications for dosing and labeling.

Huang SM, Temple R, Throckmorton DC, Lesko LJ. Huang SM, et al. Clin Pharmacol Ther. 2007 Feb;81(2):298-304. doi: 10.1038/sj.clpt.6100054. Clin Pharmacol Ther. 2007. PMID: 17259955 Review.

7

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. J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. J Clin Pharmacol. 2008. PMID: 18378963 Review.

8

Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration.

Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes A, Hammad TA, Temple R, Rochester G. Stone M, et al. BMJ. 2009 Aug 11;339:b2880. doi: 10.1136/bmj.b2880. BMJ. 2009. PMID: 19671933 Free PMC article. Review.

9

When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.

Huang SM, Temple R, Xiao S, Zhang L, Lesko LJ. Huang SM, et al. Clin Pharmacol Ther. 2009 Nov;86(5):475-9. doi: 10.1038/clpt.2009.190. Clin Pharmacol Ther. 2009. PMID: 19844224

10

Erythropoiesis-stimulating agents--time for a reevaluation.

Unger EF, Thompson AM, Blank MJ, Temple R. Unger EF, et al. N Engl J Med. 2010 Jan 21;362(3):189-92. doi: 10.1056/NEJMp0912328. Epub 2010 Jan 6. N Engl J Med. 2010. PMID: 20054037 No abstract available.

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