報(bào)批美國(guó)fda仿制藥研發(fā)與相關(guān)問(wèn)題探討-final-資料下載頁(yè)
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【正文】 Passed 案例研究 3 CASE STUDY 3 ER CAPSULES ? Brand Product – MicroTablets in Capsules – 95% of API existed in Finished Product – System and Process Patented UNIQUE SYSTEMCREATIVE DESIGN ? Compressed Granules in Capsules – Requirement ?Same Dissolution Behavior ?Uniform ?Yield Acceptable SYSTEM COMPARISON PILOT BIOSTUDY PRODUCT P DATA (Log Transformed Data, Fast, n12) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) Test A vs Reference AUC 106 。 123 Cmax 104 。 134 Test B vs Reference AUC 133 114。 155 Cmax 129 100。 167 PILOT BIOSTUDY PRODUCT P DATA (Log Transformed Data, FED, n11) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) Test A vs Reference AUC 。 123 Cmax 109 。 141 Test B vs Reference AUC 。 118 Cmax 109 。 141 PIVOTAL BIOSTUDY PRODUCT P DATA (Log Transformed Data) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) FAST AUC 102 93。 111 33,9 Cmax 105 。 116 FED AUC 。 107 Cmax 。 111 案例研究 4 CASE STUDY 4 ER CAPSULES 0204060801000 4 8 12 16 20 24Amount dissolved (%) Time (Hrs) Dissolution Profile for xxxx ER Formulation, USP Apparatus II, Water, 50 RPM RefT1T2API is Water Soluble. Prototype formulation was proposed based on in vitro dissolution (OGD method). PILOT BIOSTUDY PRODUCT DATA (Log Transformed Data) AUC0t AUC0inf Cmax T1 Ratio % % 140% 90% Geometric . % to % % to % % to % T2 Ratio % % % 90% Geometric . % to % % to % % to % Further Investigation 0204060801001200 4 8 12 16 20 24Amount dissolved (%) Time (Hrs) Simulated Dissolution for xxxx ER Formulation, RefT2謝謝! 13918667400
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