Temple RJ - Search Results

1

Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials.

Khin NA, Kronstein PD, Yang P, Ishida E, Hung HM, Mathis MV, Unger EF, Temple RJ. Khin NA, et al. Among authors: temple rj. J Clin Psychiatry. 2015 Aug;76(8):1060-3. doi: 10.4088/JCP.14cs09700. J Clin Psychiatry. 2015. PMID: 26214346

2

Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials.

O'Shaughnessy JA, Wittes RE, Burke G, Friedman MA, Johnson JR, Niederhuber JE, Rothenberg ML, Woodcock J, Chabner BA, Temple R. O'Shaughnessy JA, et al. J Clin Oncol. 1991 Dec;9(12):2225-32. doi: 10.1200/JCO.1991.9.12.2225. J Clin Oncol. 1991. PMID: 1960563

3

Government viewpoint of clinical trials of cardiovascular drugs.

Temple R. Temple R. Med Clin North Am. 1989 Mar;73(2):495-509. doi: 10.1016/s0025-7125(16)30685-x. Med Clin North Am. 1989. PMID: 2918768

4

More on the survival and ventricular enlargement trial.

Ganley CJ, Hung HM, Temple R. Ganley CJ, et al. N Engl J Med. 1993 Oct 14;329(16):1204-6. doi: 10.1056/nejm199310143291616. N Engl J Med. 1993. PMID: 8377799 No abstract available.

5

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

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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