Module 5clinicalnda
5.3.2.3 — Other Human Biomaterials
Studies using other human biomaterials (blood cells, tissues)
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
optional
Studies using other human biomaterials (blood cells, tissues)
Requirements by Phase
NDA: optional
Content Requirements
- Studies using other human biomaterials (blood cells, tissues, receptor binding)
- Studies not covered in 5.3.2.1 or 5.3.2.2
Expected Deliverables
- Study report(s) using other human biomaterials
ICH Guidelines: E3, M4E(R2)
Source: ICH M4E
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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