Module 5clinicalnda● High priority
5.3.5.3 — Analyses of Data from Multiple Studies
Integrated analyses, pooled analyses, and meta-analyses across multiple studies
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
Integrated analyses, pooled analyses, and meta-analyses across multiple studies
Requirements by Phase
NDA: required
Content Requirements
- Integrated analyses across multiple studies
- Integrated Summary of Efficacy (ISE)
- Integrated Summary of Safety (ISS)
- Pooled analyses and meta-analyses
- Cross-study comparisons
Expected Deliverables
- Integrated Summary of Efficacy (ISE)
- Integrated Summary of Safety (ISS)
- Pooled analysis report(s)
ICH Guidelines: E3, E9(R1), M4E(R2)
Source: ICH E9(R1)
References
Related Sections
Up to5.3 — Clinical Study Reports5.3.1 — Reports of Biopharmaceutic Studies
5.3.1.1 — Bioavailability Study Reports
Reports of absolute and relative bioavailability studies
5.3.1.2 — Comparative BA/BE Study Reports
Reports of comparative bioavailability and bioequivalence studies
5.3.1.3 — In Vitro–In Vivo Correlation Reports
Reports correlating in vitro dissolution to in vivo bioavailability
5.3.1.4 — Bioanalytical and Analytical Methods
Validation reports for bioanalytical methods used in human studies
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