| 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 |
