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Handboek farmaceutische geneeskunde pp 37–55Cite as

Statistiek en datamanagement

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Inleiding

We hebben dagelijks te maken met statistiek. De kranten rapporteren statistische informatie over bijvoorbeeld financiële zaken, maar ook over werkloosheid en politiek. Ook in klinisch onderzoek speelt statistiek een belangrijke rol, zeker als het gaat over wetenschappelijke publicaties. De ICH-richtlijn E6, Guideline for good clinical practice erkent de essentiële rol van statistiek in het opzetten en analyseren van klinische studies. En de ICH-richtlijn E9, Statistical principles for clinical trials is een leidraad voor het goed omgaan met statistische methodologie in klinische studies voor registratiedoeleinden.

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Author information

Authors and Affiliations

  1. Late Development Statistics, Biostatistics and Research Decision Sciences (BARDS), Pharmaceutische Statistiek en Data Management (PSDM) groep en European Federation of Statisticians in Pharmaceutical Industry (EFSPI), Oss, The Netherlands

    Egbert Biesheuvel

Authors
  1. Egbert Biesheuvel
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Editor information

Editors and Affiliations

  1. Oss, The Netherlands

    Henk Jan Out

  2. BioClinica, Leiden, The Netherlands

    Paul van Meurs

  3. GlaxoSmithKline, Zeist, The Netherlands

    Rudolf van Olden

Copyright information

© 2014 Bohn Stafleu van Loghum

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Biesheuvel, E. (2014). Statistiek en datamanagement. In: Out, H., van Meurs, P., van Olden, R. (eds) Handboek farmaceutische geneeskunde. Bohn Stafleu van Loghum, Houten. https://doi.org/10.1007/978-90-368-0265-9_4

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  • DOI: https://doi.org/10.1007/978-90-368-0265-9_4

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  • Publisher Name: Bohn Stafleu van Loghum, Houten

  • Print ISBN: 978-90-368-0264-2

  • Online ISBN: 978-90-368-0265-9

  • eBook Packages: Dutch language eBook collection

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