PubMed

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.

Clin Pharmacol Ther. 2009 Nov;86(5):475-9.PMID: 19844224 [PubMed - indexed for MEDLINE]Related articles

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.

BMJ. 2009 Aug 11;339:b2880. doi: 10.1136/bmj.b2880. Review.PMID: 19671933 [PubMed - indexed for MEDLINE]Related articlesFree article

Prevalence and risk factors predisposing to coagulopathy in patients receiving epidural analgesia for hepatic surgery.

Shontz R, Karuparthy V, Temple R, Brennan TJ.

Reg Anesth Pain Med. 2009 Jul-Aug;34(4):308-11.PMID: 19574863 [PubMed - indexed for MEDLINE]Related articles

One-on-one with AristaCare Health Services CIO Rich Temple. When a hospital is acquired, at what point does a CIO decide it's time to leave? Interview by Daphne Lawrence.

Temple R.

Healthc Inform. 2009 Apr;26(4):60, 62, 64. No abstract available. PMID: 19435104 [PubMed - indexed for MEDLINE]Related articles

IRS2 variants and syndromes of severe insulin resistance.

Bottomley WE, Soos MA, Adams C, Guran T, Howlett TA, Mackie A, Miell J, Monson JP, Temple R, Tenenbaum-Rakover Y, Tymms J, Savage DB, Semple RK, O'Rahilly S, Barroso I.

Diabetologia. 2009 Jun;52(6):1208-11. Epub 2009 Apr 18. No abstract available. PMID: 19377890 [PubMed - indexed for MEDLINE]Related articles

Early and late presentations of ethylene glycol poisoning.

Ting SM, Ching I, Nair H, Langman G, Suresh V, Temple RM.

Am J Kidney Dis. 2009 Jun;53(6):1091-7. Epub 2009 Mar 9. No abstract available. PMID: 19272685 [PubMed - indexed for MEDLINE]Related articles

Ecological validity of the neuropsychological assessment battery screening module in post-acute brain injury rehabilitation.

Temple RO, Zgaljardic DJ, Abreu BC, Seale GS, Ostir GV, Ottenbacher KJ.

Brain Inj. 2009 Jan;23(1):45-50.PMID: 19096970 [PubMed - indexed for MEDLINE]Related articles

Absence of telomere shortening and oxidative DNA damage in the young adult offspring of women with pre-gestational type 1 diabetes.

Cross JA, Brennan C, Gray T, Temple RC, Dozio N, Hughes JC, Levell NJ, Murphy H, Fowler D, Hughes DA, Sampson MJ.

Diabetologia. 2009 Feb;52(2):226-34. Epub 2008 Nov 26.PMID: 19034420 [PubMed - indexed for MEDLINE]Related articles

New therapies from old medicines.

Chen ST, Dou J, Temple R, Agarwal R, Wu KM, Walker S.

Nat Biotechnol. 2008 Oct;26(10):1077-83. No abstract available. PMID: 18846070 [PubMed - indexed for MEDLINE]Related articles

Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial.

Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC.

BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.PMID: 18818254 [PubMed - indexed for MEDLINE]Related articlesFree article

Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice.

Huang SM, Temple R.

Clin Pharmacol Ther. 2008 Sep;84(3):287-94. Review. No abstract available. PMID: 18714314 [PubMed - indexed for MEDLINE]Related articles

Drug-review deadlines and safety problems.

Nardinelli C, Lanthier M, Temple R.

N Engl J Med. 2008 Jul 3;359(1):95-6; author reply 96-8. No abstract available. PMID: 18596282 [PubMed - indexed for MEDLINE]Related articles

Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005.

Jackson K, Gersh BJ, Stockbridge N, Fleming TR, Temple R, Califf RM, Connolly SJ, Wallentin L, Granger CB; Duke Clinical Research Institute/American Heart Journal Expert Meeting on Antithrombotic Drug Development for Atrial Fibrillation.

Am Heart J. 2008 May;155(5):829-40. Review.PMID: 18440329 [PubMed - indexed for MEDLINE]Related articles

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.

J Clin Pharmacol. 2008 Jun;48(6):662-70. Epub 2008 Mar 31. Review.PMID: 18378963 [PubMed - indexed for MEDLINE]Related articles

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.

Am Heart J. 2008 Mar;155(3):435-44. Epub 2008 Jan 31. Review.PMID: 18294475 [PubMed - indexed for MEDLINE]Related articles

Specific barriers to the conduct of randomized trials.

Duley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, Chrolavicius S, Li T, Ounpuu S, Perez AC, Sleight P, Svard R, Temple R, Tsouderous Y, Yunis C, Yusuf S.

Clin Trials. 2008;5(1):40-8.PMID: 18283079 [PubMed - indexed for MEDLINE]Related articles

Sensible guidelines for the conduct of large randomized trials.

Yusuf S, Bosch J, Devereaux PJ, Collins R, Baigent C, Granger C, Califf R, Temple R.

Clin Trials. 2008;5(1):38-9. No abstract available. Erratum in: Clin Trials. 2008;5(3):283. Devereaus, Philip J [corrected to Devereaux, Philip J]. PMID: 18283078 [PubMed - indexed for MEDLINE]Related articles

Rosiglitazone and the FDA.

Joffe HV, Parks MH, Meyer RJ, Jenkins JK, Temple R.

N Engl J Med. 2007 Oct 25;357(17):1775-6; author reply 1777. Epub 2007 Aug 29. No abstract available. PMID: 17761586 [PubMed - indexed for MEDLINE]Related articles

Changes in the glycemic profiles of women with type 1 and type 2 diabetes during pregnancy.

Murphy HR, Rayman G, Duffield K, Lewis KS, Kelly S, Johal B, Fowler D, Temple RC.

Diabetes Care. 2007 Nov;30(11):2785-91. Epub 2007 Jul 31.PMID: 17666464 [PubMed - indexed for MEDLINE]Related articlesFree article

The FDA's assessment of follow-on protein products: a historical perspective.

Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, Hixon D, Joneckis C, Kozlowski S, Rosenberg A, Schrager L, Shacter E, Temple R, Webber K, Winkle H.

Nat Rev Drug Discov. 2007 Jun;6(6):437-42.PMID: 17633790 [PubMed - indexed for MEDLINE]Related articles

Quantitative decision analysis: a work in progress.

Temple R.

Clin Pharmacol Ther. 2007 Aug;82(2):127-30. No abstract available. PMID: 17632535 [PubMed - indexed for MEDLINE]Related articles

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.

Am Heart J. 2007 Jun;153(6):951-9.PMID: 17540195 [PubMed - indexed for MEDLINE]Related articles

Wisconsin Card Sorting Test: factor structure and relationship to productivity and supervision needs following severe traumatic brain injury.

Benge JF, Caroselli JS, Temple RO.

Brain Inj. 2007 Apr;21(4):395-400.PMID: 17487637 [PubMed - indexed for MEDLINE]Related articles

Trends in laryngopharyngeal reflux: a British ENT survey.

Karkos PD, Benton J, Leong SC, Karkanevatos A, Badran K, Srinivasan VR, Temple RH, Issing WJ.

Eur Arch Otorhinolaryngol. 2007 May;264(5):513-7. Epub 2007 Feb 14.PMID: 17404773 [PubMed - indexed for MEDLINE]Related articles

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

Huang SM, Temple R, Throckmorton DC, Lesko LJ.

Clin Pharmacol Ther. 2007 Feb;81(2):298-304. Review.PMID: 17259955 [PubMed - indexed for MEDLINE]Related articles

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

Temple R, Stockbridge NL.

Ann Intern Med. 2007 Jan 2;146(1):57-62.PMID: 17200223 [PubMed - indexed for MEDLINE]Related articlesFree article

Glycaemic control throughout pregnancy and risk of pre-eclampsia in women with type I diabetes.

Temple RC, Aldridge V, Stanley K, Murphy HR.

BJOG. 2006 Nov;113(11):1329-32. Epub 2006 Sep 27.PMID: 17004981 [PubMed - indexed for MEDLINE]Related articles

Is early treatment of anaemia with epoetin-alpha beneficial to pre-dialysis chronic kidney disease patients? Results of a multicentre, open-label, prospective, randomized, comparative group trial.

Macdougall IC, Temple RM, Kwan JT.

Nephrol Dial Transplant. 2007 Mar;22(3):784-93. Epub 2006 Sep 12.PMID: 16968726 [PubMed - indexed for MEDLINE]Related articlesFree article

Trends in bed occupancy for inpatients with diabetes before and after the introduction of a diabetes inpatient specialist nurse service.

Sampson MJ, Crowle T, Dhatariya K, Dozio N, Greenwood RH, Heyburn PJ, Jones C, Temple RC, Walden E.

Diabet Med. 2006 Sep;23(9):1008-15.PMID: 16922708 [PubMed - indexed for MEDLINE]Related articles

Differential impact of executive function on visual memory tasks.

Temple RO, Davis JD, Silverman I, Tremont G.

Clin Neuropsychol. 2006 Sep;20(3):480-90.PMID: 16895860 [PubMed - indexed for MEDLINE]Related articles

Prepregnancy care and pregnancy outcomes in women with type 1 diabetes.

Temple RC, Aldridge VJ, Murphy HR.

Diabetes Care. 2006 Aug;29(8):1744-9.PMID: 16873774 [PubMed - indexed for MEDLINE]Related articlesFree article

FDA perspective on trials with interim efficacy evaluations.

Temple R.

Stat Med. 2006 Oct 15;25(19):3245-9; discussion 3326-47.PMID: 16847824 [PubMed - indexed for MEDLINE]Related articles

A national survey of physicians' use of and satisfaction with neuropsychological services.

Temple RO, Carvalho J, Tremont G.

Arch Clin Neuropsychol. 2006 Aug;21(5):371-82. Epub 2006 Jul 17.PMID: 16844340 [PubMed - indexed for MEDLINE]Related articles

Investigation of biases in the general public in evaluating mild head injury using neuropsychological and CT scan results: forensic implications.

Guilmette TJ, Kennedy ML, Weiler MD, Temple RO.

Clin Neuropsychol. 2006 Jun;20(2):305-14.PMID: 16690549 [PubMed - indexed for MEDLINE]Related articles

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

Desai M, Stockbridge N, Temple R.

AAPS J. 2006 Mar 10;8(1):E146-52. Review.PMID: 16584122 [PubMed - indexed for MEDLINE]Related articlesFree article

Hy's law: predicting serious hepatotoxicity.

Temple R.

Pharmacoepidemiol Drug Saf. 2006 Apr;15(4):241-3. No abstract available. PMID: 16552790 [PubMed - indexed for MEDLINE]Related articles

The pregnancies of women with Type 2 diabetes: poor outcomes but opportunities for improvement.

Roland JM, Murphy HR, Ball V, Northcote-Wright J, Temple RC.

Diabet Med. 2005 Dec;22(12):1774-7.PMID: 16401329 [PubMed - indexed for MEDLINE]Related articles

Issues in regulatory guidelines for data monitoring committees.

DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R.

Clin Trials. 2004;1(2):162-9. Review.PMID: 16281888 [PubMed - indexed for MEDLINE]Related articles

How FDA currently makes decisions on clinical studies.

Temple R.

Clin Trials. 2005;2(4):276-81; discussion 364-78. No abstract available. PMID: 16281425 [PubMed - indexed for MEDLINE]Related articles

The influence of victim characteristics on potential jurors' perceptions of brain damage in mild traumatic brain injury.

Guilmette TJ, Temple RO, Kennedy ML, Weiler MD, Ruffolo LF, Dufresne E.

Brain Inj. 2005 Nov;19(12):1027-30.PMID: 16263645 [PubMed - indexed for MEDLINE]Related articles

Characterizing vancomycin-resistant enterococci in neonatal intensive care.

Sherer CR, Sprague BM, Campos JM, Nambiar S, Temple R, Short B, Singh N.

Emerg Infect Dis. 2005 Sep;11(9):1470-2.PMID: 16229786 [PubMed - indexed for MEDLINE]Related articlesFree article

Awareness of general practitioners towards treatment of laryngopharyngeal reflux: a British survey.

Karkos PD, Thomas L, Temple RH, Issing WJ.

Otolaryngol Head Neck Surg. 2005 Oct;133(4):505-8.PMID: 16213919 [PubMed - indexed for MEDLINE]Related articles

Enrichment designs: efficiency in development of cancer treatments.

Temple RJ.

J Clin Oncol. 2005 Aug 1;23(22):4838-9. Epub 2005 Jun 27. No abstract available. PMID: 15983397 [PubMed - indexed for MEDLINE]Related articles

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

Roden DM, Temple R.

Circulation. 2005 Apr 5;111(13):1697-702. Review. No abstract available. PMID: 15811869 [PubMed - indexed for MEDLINE]Related articlesFree article

A mobile screening programme for the cardiovascular and microvascular complications of Type 2 diabetes in primary care.

Sampson MJ, Barrie P, Dozio N, Flatman M, Hadley-Brown M, Harvey I, Heyburn PJ, Jones C, Mann R, Temple RC, Greenwood RH.

Diabet Med. 2005 Mar;22(3):256-7.PMID: 15717871 [PubMed - indexed for MEDLINE]Related articles

ROBERT TEMPLE: an eye for data. Interview.

Temple R.

Mol Interv. 2004 Dec;4(6):313-7.PMID: 15616158 [PubMed - indexed for MEDLINE]Related articlesFree article

Factors predicting local tumor control after gamma knife stereotactic radiosurgery for benign intracranial meningiomas.

DiBiase SJ, Kwok Y, Yovino S, Arena C, Naqvi S, Temple R, Regine WF, Amin P, Guo C, Chin LS.

Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1515-9.PMID: 15590183 [PubMed - indexed for MEDLINE]Related articles

Assessment of mood state in dementia by use of the visual analog mood scales (VAMS).

Temple RO, Stern RA, Latham J, Ruffolo JS, Arruda JE, Tremont G.

Am J Geriatr Psychiatry. 2004 Sep-Oct;12(5):527-30.PMID: 15353392 [PubMed - indexed for MEDLINE]Related articles

Homocysteine as a predictive factor for hip fracture in older persons.

Ellenberg SS, Orloff DG, Temple RJ.

N Engl J Med. 2004 Sep 2;351(10):1027-30; author reply 1027-30. No abstract available. PMID: 15352276 [PubMed - indexed for MEDLINE]Related articles

Partial laser turbinectomy: two year outcomes in patients with allergic and non-allergic rhinitis.

Sandhu AS, Temple RH, Timms MS.

Rhinology. 2004 Jun;42(2):81-4.PMID: 15224634 [PubMed - indexed for MEDLINE]Related articles