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What Levels of Cholesterol should be Studied and What Should be the Study Designs?

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Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents

Part of the book series: Developments in Cardiovascular Medicine ((DICM,volume 100))

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Abstract

Study design must always depend on the objectives of the trial. In this paper, I will be talking about trials in phase II, III, and IV that are intended to determine whether a drug is safe and effective for use in altering lipids and lipoproteins for prevention of coronary artery disease.

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References

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Author information

Authors and Affiliations

  1. Division of Metabolic and Endocrine Drug Products, U.S Food and Drug Administration, USA

    Gloria Troendle M.D. (Deputy Director)

Authors
  1. Gloria Troendle M.D.
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Editor information

Editors and Affiliations

  1. Likoff Cardiovascular Institute of Hahnemann Medical College and Hospital, USA

    Joel Morganroth

  2. School of Veterinary Medicine, University of Pennsylvania, USA

    E. Neil Moore

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© 1989 Kluwer Academic Publishers

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Troendle, G. (1989). What Levels of Cholesterol should be Studied and What Should be the Study Designs?. In: Morganroth, J., Moore, E.N. (eds) Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents. Developments in Cardiovascular Medicine, vol 100. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1605-3_14

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  • DOI: https://doi.org/10.1007/978-1-4613-1605-3_14

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4612-8888-6

  • Online ISBN: 978-1-4613-1605-3

  • eBook Packages: Springer Book Archive

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