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Bioavailability of imipramine tablets relative to a stable isotope-labeled internal standard: Increasing the power of bioavailability tests

  • Henry d'A Heck
  • Sidney E. ButtrillJr.
  • Norman W. Flynn
  • Robert L. Dyer
  • Michael Anbar
  • Thomas Cairns
  • Shrikant Dighe
  • Bernard E. Cabana
Article

Abstract

A new methodology for comparative bioavailability testing is described in which each drug formulation is compared with a stable isotope-labeled variant of the drug that is consumed orally in solution at the same time the tested formulation is ingested. The methodology is used to determine the comparative bioavailabilities of two commercially available brands of imipramine hydrochloride. The power of the new methodology to detect differences between drug formulations, when, in fact, such differences exist, is shown to be superior to that of conventional bioavailability tests.

Key words

bioavailability confidence intervals hypothesis testing imipramine internal standard mass spectrometry power relative bioavailability 

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Copyright information

© Plenum Publishing Corporation 1979

Authors and Affiliations

  • Henry d'A Heck
    • 1
  • Sidney E. ButtrillJr.
    • 1
  • Norman W. Flynn
    • 1
  • Robert L. Dyer
    • 1
  • Michael Anbar
    • 1
  • Thomas Cairns
    • 2
  • Shrikant Dighe
    • 2
  • Bernard E. Cabana
    • 2
  1. 1.Mass Spectrometry Research CenterStanford Research InstituteMenlo Park
  2. 2.DHEW/Public Health Service, Food and Drug AdministrationRockville

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