A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

On this paper, a particular case for bioequivalence analysis of oral formulations is mentioned. Drug formulations with completely different types of lively moieties (e.g., free base and salt) might yield completely different dissolution traits and, thus, differ in absorption at elevated gastric pH. Nevertheless, routine bioequivalence trials utilizing topics with regular gastric pH (i.e., ~ […]

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