Temple R - Search Results

1

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.

Blaus A, Madabushi R, Pacanowski M, Rose M, Schuck RN, Stockbridge N, Temple R, Unger EF. Blaus A, et al. Among authors: temple r. Circulation. 2015 Oct 13;132(15):1425-32. doi: 10.1161/CIRCULATIONAHA.114.009761. Circulation. 2015. PMID: 26459078

2

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.

3

The US Food and Drug Administration Cardiorenal Advisory Panel and the drug approval process.

Roden DM, Temple R. Roden DM, et al. Among authors: temple r. Circulation. 2005 Apr 5;111(13):1697-702. doi: 10.1161/01.CIR.0000161370.77463.0F. Circulation. 2005. PMID: 15811869 Review. No abstract available.

4

Blood pressure as an example of a biomarker that functions as a surrogate.

Desai M, Stockbridge N, Temple R. Desai M, et al. Among authors: temple r. AAPS J. 2006 Mar 10;8(1):E146-52. doi: 10.1208/aapsj080117. AAPS J. 2006. PMID: 16584122 Free PMC article. Review.

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

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.

7

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.

8

Preventing tomorrow's sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy.

Sanders GD, Al-Khatib SM, Berliner E, Bigger JT, Buxton AE, Califf RM, Carlson M, Curtis AB, Curtis JP, Domanski M, Fain E, Gersh BJ, Gold MR, Goldberger J, Haghighi-Mood A, Hammill SC, Harder J, Healey J, Hlatky MA, Hohnloser SH, Lee KL, Mark DB, Mitchell B, Phurrough S, Prystowsky E, Smith JM, Stockbridge N, Temple R; Expert panel participating in a Duke Center for the Prevention of Sudden Cardiac Death-sponsored conference. Sanders GD, et al. Among authors: temple r. Am Heart J. 2007 Jun;153(6):951-9. doi: 10.1016/j.ahj.2007.03.002. Am Heart J. 2007. PMID: 17540195

9

Clinical and research issues regarding chronic advanced coronary artery disease part II: Trial design, outcomes, and regulatory issues.

Jolicoeur EM, Ohman EM, Temple R, Stockbridge N, Smith S, Mark D, Califf RM, Henry TD, Chaitman BR, Granger CB; Working Group Members. Jolicoeur EM, et al. Among authors: temple r. Am Heart J. 2008 Mar;155(3):435-44. doi: 10.1016/j.ahj.2007.12.005. Epub 2008 Jan 31. Am Heart J. 2008. PMID: 18294475 Review.

10

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.

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