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 />
FDA Proposed<br />
Wyeth Proposed<br />
Time (Hr) Mean Lower Upper Lower Upper<br />
1 48 38 58 36 60<br />
4 78 68 88 69 87<br />
12 82 NLT 80 NLT 73<br />
Parameter<br />
Simulated Bioavailability Parameters<br />
AUC 4834 4339 5302 4257 5216<br />
% Diff from Mean<br />
-- 10% 10% 12% 8%<br />
% Diff Lower to<br />
Upper -- 18% 18%<br />
Cmax<br />
578 544 659 558 688<br />
% Diff from Mean<br />
-- 6% 14% 3% 19%<br />
% Diff Lower to<br />
Upper -- 17% 19%
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