• 1
    Turner JR. The 50th anniversary of the Kefauver-Harris Amendments: efficacy assessment and the randomized clinical trial. J Clin Hypertens (Greenwich). 2012;14:810815.
  • 2
    Durham TA, Turner JR. Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press; 2008.
  • 3
    Turner JR. Key Statistical Concepts in Clinical Trials for Pharma. New York: Springer; 2012.
  • 4
    FDA. The Sentinel Initiative: National strategy for monitoring medical product safety. May 2008. Accessed January 14, 2013.
  • 5
    Herxheimer A. Consumer Organizations. In: Inman WHW, ed. Monitoring for Drug Safety, 2nd ed. Hingham, MA: MTP Press; 1986:699704.
  • 6
    Piantadosi S. Clinical Trials: A Methodologic Perspective, 2nd ed. Hoboken, NJ: Wiley-Interscience; 2005.
  • 7
    Turner JR. Editor's commentary: ethics in clinical research. Drug Inf J. 2012;46:155157.
  • 8
    FDA Web site. Accessed January 14, 2013.
  • 9
    EMA Web site. Accessed January 14, 2013.
  • 10
    PMDA Web site. Accessed January 14, 2013.
  • 11
    ICH Web site. Accessed January 9, 2013.
  • 12
    ICH Guideline E8: General Considerations for Clinical Trials. July 1997. Accessed January 9, 2013.
  • 13
    Wang L, Ma C, Wipf P, et al. TargetHunter: an in silico target identification tool for predicting therapeutic potential of small organic molecules based on chemogenomic database. AAPS J. 2013 Jan 5; [Epub ahead of print].
  • 14
    Gad SC ed. Preclinical Development Handbook. Hoboken, NJ: John Wiley & Sons; 2008.
  • 15
    Turner JR. New Drug Development: An Introduction to Clinical Trials, 2nd ed. New York: Springer; 2010.
  • 16
    EMA. Guideline on clinical investigation of medicinal products in the treatment of hypertension. November 2010. Accessed January 16, 2013.
  • 17
    Bakris GL, Sica D, White WB, et al. Antihypertensive efficacy of hydrochlorothiazide vs chlorthalidone combined with azilsartan medoxomil. Am J Med. 2012;125:1229.e11229.e10.
  • 18
    The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. J Clin Epidemiol. 1988;41:11971208.
  • 19
    SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265:32553264.
  • 20
    ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). JAMA. 2000; 283:19671975.
  • 21
    Jamerson K, Weber MA, Bakris GL, et al. ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008;359:24172428.
  • 22
    Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press; 2007.
  • 23
    Strom BL. Pharmacoepidemiology, 4th ed. Chichester, UK: John Wiley & Sons; 2005.