Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects
Turki A. Althunian,
Bader R. Alzenaidy,
Raseel A. Alroba
et al.
Abstract:Background
This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Methods
This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the… Show more
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