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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%

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