Sponsors Request More Bioequivalence Details in EMA Guideline on Multi-Region Clinical Trials

February 17, 2017

Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials that span multiple regions.

In comments on the E17 draft guideline developed by the International Council for Harmonisation, the Association of Clinical Research Organizations said different ICH countries can define bioequivalence in different ways—and that regulatory agencies should have an established method to discuss and agree on a single clinical trial protocol.

ACRO also said the guideline should account for situations where in vitro dissolution data, rather than in vivo studies, could be suitable for confirming bioequivalence.

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