The Role of in Vitro-in Vivo Correlations (IVIVC) to Regulatory Agencies
Dissolution testing remains a potentially powerful and nearly always useful method for obtaining data related to quality and, potentially, clinical performance of dosage forms, especially solid oral dosage forms. But, not surprisingly, dissolution is not always a surrogate for bioequivalence, which necessitates human testing for determination of bioequivalence in many instances. The key to confidence in dissolution testing is the strength of the relationship between dissolution and bioequivalence, in other words, the ability of dissolution testing to predict in vivo performance. Therefore, the availability of an IVIVC, as well as the type of dissolution testing conducted, are important considerations.
KeywordsExtended Release Dissolution Profile Dissolution Testing Immediate Release Draft Guidance
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