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 OF<br />
LEVEL A <strong>IVIVC</strong> FOR 200 mg MR TABLETS<br />
Batch<br />
15% HPMC<br />
Roller<br />
Compact<br />
MFG Site A<br />
30% HPMC<br />
Roller<br />
Compact<br />
MFG Site A<br />
Batch<br />
30% HPMC<br />
Wet<br />
Granulation<br />
MFG Site B<br />
Observed<br />
AUC<br />
Predicted<br />
AUC<br />
Intern al Predictability<br />
Absolute<br />
% PE<br />
Observed<br />
Cmax<br />
Predicted<br />
Cmax<br />
Absolute<br />
% PE<br />
8870 9094 2.53 362 344 4.95<br />
8984 9218 2.61 314 307 2.07<br />
Observed<br />
AUC<br />
Average % PE 2.57 Averag e % PE 3.51<br />
Predicted<br />
AUC<br />
External Predictability<br />
Absolute<br />
% PE<br />
Observed<br />
Cmax<br />
Predicted<br />
Cmax<br />
Absolute<br />
% PE<br />
8540 8772 2.72 308 309 0.36<br />
AUC units: ng·hr/mL; Cmax units: ng/mL
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