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Pharmacokinetics of Contraceptive Steroids in Humans

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Part of the book series:Reproductive Biology ((PBTS))

Abstract

In contrast to our longstanding and enormous clinical experience with contraceptive steroids, most of our knowledge about the pharmacokinetics of these drugs in man has been obtained only in recent years, appears limited and, in many aspects, is quite inadequate. A major obstacle used to be the lack of reliable radioimmunoassays (RIAs) to determine the minute concentrations of contraceptive steroids in serum or plasma. This problem has been solved to a certain degree in recent years. Yet, a number of methodological problems and inadequacies remain, not only with regard to RIAs but also with regard to subject selection, dosing, sampling, conditions of study as well as data analysis. Meaningful pharmacokinetic studies of contraceptive steroids in humans are laborious and costly. However, such studies are essential for the selection and timing of drug doses, for evaluating the pharmacokinetic action and particularly for the selection of appropriate animal models and the design of animal toxicity studies. If the pharmacokinetics of a certain contraceptive steroid in a given animal model differ significantly from the human pharmacokinetics of this drug, then the particular animal model is unsuitable for pharmacokinetic and toxicologic studies of this contraceptive steroid.

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Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, UCLA College of Medicine, Los Angeles, California, USA

    Uwe Goebelsmann (Moderator)

Authors
  1. Uwe Goebelsmann

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Editors and Affiliations

  1. Food and Drug Administration, RockVille, Maryland, USA

    A. T. Gregoire

  2. National Institutes of Health, Bethesda, Maryland, USA

    Richard P. Blye

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© 1986 Plenum Press, New York

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Goebelsmann, U. (1986). Pharmacokinetics of Contraceptive Steroids in Humans. In: Gregoire, A.T., Blye, R.P. (eds) Contraceptive Steroids. Reproductive Biology. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-2241-2_4

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