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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Sett<strong>in</strong>g <strong>of</strong> Dissolution Specifications<br />
Dissolution at Release<br />
Dissolution at Release (%)<br />
and After 3 Months (%)<br />
Time (Hr) Mean -10% +10% -3 SD +3 SD Mean - 3SD +3 SD<br />
2 21 11 31 15 27 22 16 28<br />
4 53 43 63 47 59 54 49 59<br />
5 64 54 74 58 70 65 60 69<br />
8 85 75 95 78 92 86 82 91<br />
12 97 87 107 90 104 98 93 103<br />
Simulated Bioavailability Parameters<br />
Parameter Mean -10% +10% -3 SD +3 SD Mean - 3SD +3 SD<br />
AUC 69.8 62.7 77.0 64.9 73.9 69.6 65.0 73.6<br />
% Diff from<br />
Mean -- 10.2 10.4 7.0 6.0 -- 6.6 5.6<br />
% Diff Low<br />
to High -- 18.6 12.2 -- 11.6<br />
Cmax 2.76 2.47 3.04 2.55 2.97 2.76 2.64 2.89<br />
% Diff from<br />
Mean -- 10.4 10.2 7.6 7.5 -- 4.2 4.8<br />
% Diff Low<br />
to High -- 18.8 14.1 -- 8.6
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