Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
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Case Study 5<br />
BCS Class I Drug<br />
<strong>Development</strong> <strong>of</strong> <strong>IVIVC</strong> for Marketed MR Product<br />
Change <strong>in</strong> process<br />
Multiple strengths manufactured and exhibit same <strong>in</strong><br />
vitro dissolution release pr<strong>of</strong>ile<br />
Retrospective analysis <strong>of</strong> data available from 7 BA<br />
studies<br />
Drug has significant first-pass metabolism<br />
Data from <strong>in</strong>tubation study <strong>in</strong>dicated <strong>in</strong>crease <strong>in</strong> systemic availability <strong>in</strong><br />
distal GI<br />
Correlation model developed us<strong>in</strong>g dissolution data<br />
directly as <strong>in</strong>put<br />
First derivative <strong>of</strong> Weibull Function