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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Dissolution Specifications For Low Dose<br />
Formuation<br />
Dissolution<br />
<strong>IVIVC</strong> Based<br />
Absence <strong>of</strong> <strong>IVIVC</strong><br />
Time (Hr) Mean Lower Upper Lower Upper<br />
1 48 39 57 38 58<br />
4 78 69 87 68 88<br />
12 82 NLT 73 NLT 72<br />
Parameter<br />
Simulated Bioavailability Parameters<br />
AUC 4834 4240 5322 4179 5382<br />
% Diff from Mean<br />
-- 12% 10% 14% 11%<br />
% Diff Lower to<br />
Upper -- 20% 22%<br />
Cmax<br />
578 531 649 525 655<br />
% Diff from Mean<br />
-- 8% 12% 9% 13%<br />
% Diff Lower to<br />
Upper -- 18% 20%