Skip to main content
SpringerLink
Log in
Book cover

Good Clinical Practice II pp 3–18Cite as

Überlegungen zur Entwicklung individueller nichtklinischer Prüfstrategien in der Europäischen Gemeinschaft

  • Conference paper

  • 78 Accesses

Part of the book series: Konzepte in der Humanpharmakologie ((KONZHUMAN))

Zusammenfassung

Im Rahmen der Entwicklung neuer Wirkstoffe und deren Formulierungen zu zulassungsfähigen Arzneimittelspezialitäten ist eine Fülle pharmakodynamischer, pharmakokinetischer und toxikologischer Untersuchungen erforderlich.

This is a preview of subscription content, 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   64.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   84.99
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

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Literatur

  1. Alder S, Zbinden, G National and international drug safety guidelines. MTC Verlag, Zollikon, 1988

    Google Scholar 

  2. US Department of Health, Education and Welfare, Public Health Service, Food and Drug Administration, Rockville, Md FDA Introduction to total drug quality. DHEW Publication No (FDA) 74-3006, November 1973

    Google Scholar 

  3. Commission of the European Communities, CPMP Working Party on Safety of Medicinal Products, Brüssel Note for Guidance, Recommendations for the development of non-clinical testing strategies, III/58/89-EN, Draft No. 7, 5 July 1990

    Google Scholar 

  4. The World Medical Association Inc, Ferney-Voltaire, France. World Medical Association Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects. Last adoption by the 41st World Medical Assembly, Hong Kong, September 1989

    Google Scholar 

  5. Popper, KR, Objektive Erkenntnis — Ein evolutionärer Entwurf. Hoffmann und Campe, Hamburg, 1974, S.95

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Institut für Arzneimittel des Bundesgesundheitsamtes, Schering AG, Berlin/Bergkamen, Deutschland

    P. Günzel & R. Baß

Authors
  1. P. Günzel
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. R. Baß
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Institut für Humanpharmakologie, Schering AG, Müllerstraße 170-178, W-1000, Berlin 65, Deutschland

    Lothar Lange  & Wolf Seifert  & 

  2. LAB Gesellschaft für pharmakologische Untersuchungen mbH & Co., Postfach 1680, W-7910, Neu-Ulm, Deutschland

    Halvor Jaeger  & Ingrid Klingmann  & 

Rights and permissions

Reprints and permissions

Copyright information

© 1992 Springer-Verlag Berlin Heidelberg

About this paper

Cite this paper

Günzel, P., Baß, R. (1992). Überlegungen zur Entwicklung individueller nichtklinischer Prüfstrategien in der Europäischen Gemeinschaft. In: Lange, L., Seifert, W., Jaeger, H., Klingmann, I. (eds) Good Clinical Practice II. Konzepte in der Humanpharmakologie. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-84729-5_1

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-84729-5_1

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-84730-1

  • Online ISBN: 978-3-642-84729-5

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation