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