Module 5clinicalnda● High priority
5.3.1.4 — Bioanalytical and Analytical Methods
Validation reports for bioanalytical methods used in human studies
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
optional
NDA
required
Validation reports for bioanalytical methods used in human studies
Requirements by Phase
IND Phase 3: optional NDA: required
Content Requirements
- Reports of bioanalytical and analytical methods for human studies
- Method validation (accuracy, precision, selectivity, sensitivity)
- Incurred sample reanalysis results
- Chromatographic and detection conditions
Expected Deliverables
- Bioanalytical method validation report
- Analytical method report for clinical samples
ICH Guidelines: E3, M4E(R2)
Source: FDA Bioanalytical Method Validation Guidance
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
5.3.2 — Reports of Studies Using Human Biomaterials
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