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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Validation <strong>of</strong> Level A <strong>IVIVC</strong> for MR Tablets<br />
Internal Predictability<br />
Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE<br />
2x50 mg 4754 4273 10.1 169 172 1.82<br />
1x100 mg 4626 4273 7.64 173 172 0.75<br />
1x200 mg 9383 8550 8.88 321 333 3.58<br />
Average % PE 8.88 Average % PE 2.05<br />
External Predictability<br />
2x75 mg 7037 6480 8.94 246 264 7.35<br />
AUC units: mcg-hr/mL, C max units: mcg/mL
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