Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies.

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 different APIs. Bioequivalence study conditions and acido-basic/solubility characteristics of APIs were collected and their predictive potential on the study outcome was assessed using a set of univariate statistical analyses.

Results

There was no difference in bioequivalence rate between fasting and fed con

SUBMITTER: Krajcar D 

PROVIDER: S-EPMC10439087 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature