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> for Drug from Low Dose <strong>Formulation</strong> Candidates<br />
Internal Predictability<br />
Formula Obs AUC Pred AUC %PE Obs C max Pred C max %PE<br />
8.0%<br />
Polymer<br />
7.0%<br />
Polymer<br />
4.5%<br />
Polymer<br />
5.25%<br />
Polymer<br />
6.25%<br />
Polymer<br />
6.5%<br />
Polymer<br />
3829 3990 4.21 488 476 2.41<br />
4456 4624 3.77 461 518 12.2<br />
5357 5581 4.19 706 716 1.42<br />
Average % PE 4.06 Average % PE 5.36<br />
External Predictability<br />
5252 5428 3.35 628 650 3.50<br />
4963 5116 3.08 578 572 1.00<br />
4454 4613 3.57 494 523 5.79<br />
AUC units: pg-hr/mL, C max units: pg/mL
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