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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Internal and External Predictability Measures <strong>of</strong> the Level A<br />
<strong>IVIVC</strong><br />
Internal Predictability<br />
Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE<br />
Slow<br />
Release<br />
Medium<br />
Release<br />
Fast<br />
Release<br />
853 916 7.37 45.3 40.8 10.0<br />
885 917 3.62 53.1 42.8 19.4<br />
880 908 3.23 58.8 54.0 8.13<br />
Average % PE 4.74 Average % PE 12.5<br />
External Predictability<br />
2x75mg 1703 1622 4.74 96.5 94.0 2.59<br />
1x150mg 1647 1622 1.51 94.4 91.1 3.50<br />
AUC units: mcg-hr/mL, C max units: mcg/mL
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