Abstract:Background and Objectives
Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development. The objective of this research was to evaluate the associations between solubility and acido-basic parameters of an active pharmaceutical ingredient (API), study conditions and bioequivalence outcome.
Methods
We retrospectively analyzed 128 bioequivalence studies of immediate-release products with 26 diffe… Show more
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