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PK bioequivalence testing when between-batch variability is high: A multiple-batch proposal

  • Publication Date: 12/01/2017
  • Author(s):
    Borgström, Lars Olsson, Bo Sandell, Dennis
  • Organization(s):
    Emmace Consulting AB S5 Consulting
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
A proposal that reduces the risk of false failures to show PK BE, with no serious drawbacks and without increasing the risk of wrongly concluding BE

Instead of comparing two batches, the mixture of several batches (possibly for both test and reference) is compared in a standard two-way cross-over study, which is analyzed in the usual way (disregarding batch identity), thus comparing the products rather than two batches.

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