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Drugs

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 (BA) Studies
m2
27-clin-Sum
2.7.1.3 Comparison and Analysis of Results Across Studies
3
Statistical Summary of the Comparative BA 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
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
m2
27-clin-Sum
2.7.1.2 Summary of Results of Individual Studies
10
Study Information
m2
27-clin-Sum
2.7.1.1 Background and Overview
11
Product Information
m2
27-clin-Sum
2.7.1.1 Background and Overview
12
Dropout Information
m2
27-clin-Sum
2.7.1.2 Summary of Results of Individual Studies
13
Protocol Deviation
m2
27-clin-Sum
2.7.1.2 Summary of Results of Individual Studies
14
Summary of Standard Curve and QC Data for Bioequivalence Sample Analysis
m2
27-clin-Sum
2.7.1.2 Summary of Results of Individual Studies
15
SOPs Dealing with Bioanalytical Repeats of Study Samples
m2
27-clin-Sum
2.7.1.4 Appendix
16
Composition of Meal Used in Fed Bioequivalence Study
m2
27-clin-Sum
2.7.1.3 Comparison and Analysis of Results Across Studies

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