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 2<br />
BCS Class II Drug<br />
Highly variable pharmacok<strong>in</strong>etics<br />
AUC and Cmax dependent upon <strong>in</strong>put rate<br />
Reformulation <strong>of</strong> generic formulation to IR reference<br />
drug products at three dose levels<br />
Controlled release required to achieve bioequivalence<br />
to reference drug product<br />
<strong>IVIVC</strong> desired to support change <strong>in</strong> tablet coat<strong>in</strong>g and<br />
change <strong>in</strong> site <strong>of</strong> manufacture