How and When Should Long-Term Safety Data be Obtained for Hypolipidemic Agents?

  • L. Ross Pierce
Part of the Developments in Cardiovascular Medicine book series (DICM, volume 100)


The aim of long-term safety data aquisition is to better define the frequency of adverse reactions suspected, but not definitely established to be drug-related on the basis of shorter-term trials, to detect toxicity that may depend on some threshold of cumulative dose or exposure duration, as well as to define the spectrum of lower-frequency reactions associated with the use of a given drug. This is a formidable goal, yet crucial to our rational understanding of how potential benefit compares to potential risk as we make treatment decisions in actual practice.


Familial Hypercholesterolemia Familial Hypercholesterolemia Familial Hypercholesterolemia Patient Heterozygous Familial Hypercholesterolemia Bile Acid Binder 
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Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • L. Ross Pierce
    • 1
  1. 1.Division of Metabolism and Endocrine Drug Products, Center for Drug Evaluation and ResearchFood and Drug AdministrationUSA

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