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Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs

Location of Summary Data Tables in Bioequivalence Submissions to ANDAs in eCTD and paper CTD
Table Name of Summary Data Table Corresponding Module in eCTD Corresponding Folder in eCTD Corresponding Module/Section in paper CTD
1 Submission Summary m2 27-clin-sum 2.7.1.1. Background and Overview
2 Summary of Bioavailability Studies m2 27-clin-sum 2.7.1.3. Comparison and Analysis of Results Across Studies
3 Statistical Summary of the Comparative Bioavailability Data m2 27-clin-sum 2.7.1.3. Comparison and Analysis of Results Across Studies
4 Bioanalytical Method Validation m2 27-clin-sum 2.7.1.1. Background and Overview
5 Summary of In Vitro Dissolution Studies m2 27-clin-sum 2.7.1.2. Summary of Results of Individual Studies
6 Formulation Data m2 27-clin-sum 2.7.1.1. Background and Overview
7 Demographic Profile of Subjects Completing the Bioequivalence Study m2 27-clin-sum 2.7.4.1.3. Demographic and Other Characteristics of Study Population
8 Incidence of Adverse Events in Individual Studies m2 27-clin-sum 2.7.4.2.1.1. Common Adverse Events
9 Reanalysis of Study Samples m5
52-tab-list
531-rep-biopharm-stud		 5314-bioanalyt-analyt-met
study-report-no.		 5.3.1.4. Report of Bioanalytical and Analytical Methods for Human Studies
10 Study Information m5
52-tab-list
531-rep-biopharm-stud		 5312-compar-ba-be-stud-rep
study-report-no.		 5.3.1.2. Comparative Bioavailability and Bioequivalence Study Reports
11 Product Information m5
52-tab-list
531-rep-biopharm-stud		 5313-in-vitro-in-vivo-corr-stud-rep
study-report-no.		 5.3.1.3. In Vitro In Vivo Correlation Study Reports
12 Dropout Information m5
52-tab-list
531-rep-biopharm-stud		 5312-compar-ba-be-stud-rep
study-report-no.		 5.3.1.2. Comparative Bioavailability and Bioequivalence Study Reports
13 Protocol Deviations m5
52-tab-list
531-rep-biopharm-stud		 5312-compar-ba-be-stud-rep
study-report-no.		 5.3.1.2. Comparative Bioavailability and Bioequivalence Study Reports
14 Summary of Standard Curve and QC Data for Bioequivalence Sample Analyses m5
52-tab-list
531-rep-biopharm-stud		 5314-bioanalyt-analyt-met
study-report-no.		 5.3.1.4. Report of Bioanalytical and Analytical Methods for Human Studies
15 SOPs dealing with Bioanalytical Repeats of Study Samples m5
52-tab-list
531-rep-biopharm-stud		 5314-bioanalyt-analyt-met
study-report-no.		 5.3.1.4. Report of Bioanalytical and Analytical Methods for Human Studies
16 Composition of Meal Used in Fed Bioequivalence Study m5
52-tab-list
531-rep-biopharm-stud		 5312-compar-ba-be-stud-rep
study-report-no.		 5.3.1.3. Comparative Bioavailability and Bioequivalence Study Reports

 

    
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