Module 5clinicalnda● Critical
5.3.3.2 — Patient PK and Tolerability
PK and tolerability studies in target patient population
Requirements by Phase
Phase 1
N/A
Phase 2
protocol
Phase 3
report
NDA
required
PK and tolerability studies in target patient population
Requirements by Phase
IND Phase 2: protocol IND Phase 3: report NDA: required
Content Requirements
- PK and tolerability studies in target patient populations
- Full CSR per ICH E3 format
- PK parameter comparison with healthy subjects if applicable
Expected Deliverables
- Patient PK study report (ICH E3 format)
ICH Guidelines: E3, M4E(R2)
Source: ICH E3
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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