Temple R - Search Results

1

Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration.

Borges S, Chen YF, Laughren TP, Temple R, Patel HD, David PA, Mathis M, Unger E, Yang P, Khin NA. Borges S, et al. Among authors: temple r. J Clin Psychiatry. 2014 Mar;75(3):205-14. doi: 10.4088/JCP.13r08722. J Clin Psychiatry. 2014. PMID: 24717376 Review.

2

FDA perspective on trials with interim efficacy evaluations.

Temple R. Temple R. Stat Med. 2006 Oct 15;25(19):3245-9; discussion 3326-47. doi: 10.1002/sim.2631. Stat Med. 2006. PMID: 16847824

3

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.

4

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. Among authors: temple r. Clin Pharmacol Ther. 2007 Feb;81(2):298-304. doi: 10.1038/sj.clpt.6100054. Clin Pharmacol Ther. 2007. PMID: 17259955 Review.

5

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.

6

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. Among authors: temple r. BMJ. 2009 Aug 11;339:b2880. doi: 10.1136/bmj.b2880. BMJ. 2009. PMID: 19671933 Free PMC article. Review.

7

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. Among authors: temple r. Clin Pharmacol Ther. 2009 Nov;86(5):475-9. doi: 10.1038/clpt.2009.190. Clin Pharmacol Ther. 2009. PMID: 19844224

8

Erythropoiesis-stimulating agents--time for a reevaluation.

Unger EF, Thompson AM, Blank MJ, Temple R. Unger EF, et al. Among authors: temple r. 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.

9

Therapeutic protein-drug interactions and implications for drug development.

Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, Lesko LJ. Huang SM, et al. Among authors: temple r. Clin Pharmacol Ther. 2010 Apr;87(4):497-503. doi: 10.1038/clpt.2009.308. Epub 2010 Mar 3. Clin Pharmacol Ther. 2010. PMID: 20200513

10

Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran.

Beasley BN, Unger EF, Temple R. Beasley BN, et al. Among authors: temple r. N Engl J Med. 2011 May 12;364(19):1788-90. doi: 10.1056/NEJMp1103050. Epub 2011 Apr 13. N Engl J Med. 2011. PMID: 21488759 Free article. No abstract available.

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