Skip to main content
SpringerLink
Log in

Design and evaluation of studies on drug delivery systems

  • Chapter
Comparative Veterinary Pharmacology, Toxicology and Theraphy

  • 354 Accesses

Abstract

The definition of bioavailability and acceptable procedures to determine bioavailability of drug delivery systems are considered in this chapter. Pharmacokinetic methods to estimate the rate and extent of absorption by drug concentration measurements in plasma and urine are discussed. Principles relevant to the design, statistical analysis and clinical interpretation of bioavailability studies are reviewed.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. American Food Drug Administration (1977). Bioavailability and bioequivalence requirements. Fed. Reg. 42: 1624–1653

    Google Scholar 

  2. American Food and Drug Administration (1982). Bio- equivalence study guideline. Bureau of Veterinary Medicine.

    Google Scholar 

  3. Cochran, U.G. and Cox, G.M. (1957). Experimental Designs, 2nd ed. New York: Wiley.

    Google Scholar 

  4. Gibaldi, M. and Perrier, D. (1982). Pharmacokinetics. 2nd ed. New York: Marcel Dekker.

    Google Scholar 

  5. Metzler, C.M. and Huang, D.C. (1983). Statistical methods for bioavailability and bioequivalence. Clin. Res. Pract. Drug Reg. Affairs 1: 109–132.

    Article  Google Scholar 

  6. Steinijans, V.W. and Diletti, E. (1983). Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur. J. Clin. Pharmacol. 24: 127–136.

    Article  PubMed  CAS  Google Scholar 

  7. Yamaoka, K., Nakagaua, T. and Uno, T. (1978). Statistical moments in pharmacokinetics. J. Pharmacokin. Biopharm. 6: 547 - 558.

    Article  CAS  Google Scholar 

Download references

Authors
  1. A. Van Peer
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. J. Heykants
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Institute of Veterinary Pharmacology, Pharmacy and Toxicology, Faculty of Veterinary Medicine, University of Utrecht, P. O. Box 80. 176, 3508 TD, Utrecht, The Netherlands

    A. S. J. P. A. M. Van Miert

  2. J. F. and C. Heymans Institute of Pharmacology, University of Ghent, Medical School, De Pintelaan 185, B-9000, Ghent, Belgium

    M. G. Bogaert

  3. Department of Veterinary Pharmacology and Toxicology, Faculty of Veterinary Medicine, University of Ghent, Casinoplein 24, B-9000, Ghent, Belgium

    M. Debackere

Rights and permissions

Reprints and permissions

Copyright information

© 1986 MTP Press Limited

About this chapter

Cite this chapter

Van Peer, A., Heykants, J. (1986). Design and evaluation of studies on drug delivery systems. In: Van Miert, A.S.J.P.A.M., Bogaert, M.G., Debackere, M. (eds) Comparative Veterinary Pharmacology, Toxicology and Theraphy. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-4153-3_7

Download citation

  • DOI: https://doi.org/10.1007/978-94-009-4153-3_7

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-8343-0

  • Online ISBN: 978-94-009-4153-3

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation