Advertisement

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)

Abstract

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.

Keywords

Familial Hypercholesterolemia Familial Hypercholesterolemia Familial Hypercholesterolemia Patient Heterozygous Familial Hypercholesterolemia Bile Acid Binder 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

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

Personalised recommendations