pilot replicate design [RSABE / ABEL]

posted by khaoula – Algeria, 2014-11-19 13:00 (3444 d 17:30 ago) – Posting: # 13876
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Hi everybody !!!

please, If we suspect that gastro-resistant capsules of omeprazole are highly variable drug product, can we do a PILOTE replicate study? to determine the within subject variability of the reference formulation and widening the bioequivalence limits if CV CR > 30%
thank you

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