Good Clinical Laboratory Practice
- Good Clinical Laboratory Practice
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Good Clinical Laboratory Practice (GCLP) ist eine GxP Richtlinie für Laborproben aus Klinischen Studien.
Da GCP keine Anforderungen an Prüflabors definiert und GLP für vorklinische Versuche entwickelt wurde und daher nicht auf die spezielle Behandlung von humanen Laborproben aus Klinischen Studien eingeht, wurde 2003 von der British Association of Research Quality Assurance (BARQA) eine Richtlinie vorgeschlagen, die diese Lücke schließen sollte. Später brachten die WHO und die Britische Gesundheitsbehörde MHRA eigene Versionen einer GCLP Richtlinie heraus.
Literatur
- World Health Organization: Good Clinical Laboratory Practice (GCLP). World Health Organization, Genf 2009, ISBN 978-92-4-159785-2.
- W.Stevens (2003): Good Clinical Laboratory Practice (GCLP). The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. In: Quality Assurance. Vol. 10, Nr. 2, April/June 2003, ISSN 1052-9411, S. 83–89.
Weblinks
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