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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Level A <strong>IVIVC</strong> Validation – Acetate Buffer<br />
as Dissolution Medium<br />
Internal Predictability<br />
Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE<br />
Slow<br />
Release<br />
Fast<br />
Release<br />
63.4 65.9 3.94 1.77 1.83 3.22<br />
74.1 78.2 5.47 3.45 3.15 8.64<br />
Average %PE 4.69 Average %PE 5.93<br />
External Predictability<br />
Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE<br />
Medium<br />
Release<br />
Target<br />
Release<br />
66.8 67.1 0.41 2.26 2.16 4.56<br />
87.1 85.5 1.87 3.92 3.56 9.18<br />
AUC units: ng-hr/mL, C max units: ng/mL
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