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Qualitätsmaßstäbe für medizinische Laboratorien in klinischen Studien

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Zusammenfassung

Die Anforderungen von GLP, GMP und GCP (GXP) sichern die Qualität der Arzneimittelentwicklung. Bisher gab es für labormedizinische Analysen keine GXP-Richtlinie. Diese Lücke wurde mit einem Reflection Paper der EMA kürzlich geschlossen.

Abstract

GLP, GMP and GCP (GXP) are important quality standards in drug development. There have been no comparable GXP-standards for lab work in clinical trials so far. This gap has been closed by a Reflection Paper recently issued by the EMA.

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Literatur

  1. [1]

    European Medicines Agency (EMA) (1996) Note for Guidance on Good Clinical Practice; CPMP/ICH/135/95. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

  2. [2]

    European Medicines Agency (EMA) (2010) Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples. EMA/INS/GCP/532137/2010. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/09/WC500096987.pdf

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Correspondence to Stephan Wnendt.

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Wnendt, S. Qualitätsmaßstäbe für medizinische Laboratorien in klinischen Studien. Biospektrum 17, 704 (2011). https://doi.org/10.1007/s12268-011-0112-5

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