Module 4nonclinicalpharmacokineticsndaind● Low priority
4.2.2.7 — Other PK Studies
Other PK studies not covered in sections 4.2.2.1-4.2.2.6
Requirements by Phase
Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
optional
Other PK studies not covered in sections 4.2.2.1-4.2.2.6
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: optional
Content Requirements
- Studies in nonclinical models of disease (e.g., renally impaired animals)
- Other PK studies not covered in sections 4.2.2.1-4.2.2.6
- Special population PK in animal models
Expected Deliverables
- Study report per ICH E3 format (if performed)
ICH Guidelines: M3(R2)
Source: ICH M3(R2)
References
Related Sections
Up to4.2.2 — Pharmacokinetics4.2.2.1 — Analytical Methods and Validation (PK)
Bioanalytical method development and validation for PK studies in toxicology species
4.2.2.2 — Absorption
Absorption studies including bioavailability, rate and extent of absorption
4.2.2.3 — Distribution
Tissue distribution studies including plasma protein binding and tissue uptake
4.2.2.4 — Metabolism
In vitro and in vivo metabolism studies, metabolite identification and profiling
4.2.2.5 — Excretion
Mass balance and routes of excretion studies
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