Module 4nonclinicalpharmacokineticsndaind● Critical
4.2.2.1 — Analytical Methods and Validation (PK)
Bioanalytical method development and validation for PK studies in toxicology species
Requirements by Phase
Phase 1
required
Phase 2
required
Phase 3
required
NDA
required
Bioanalytical method development and validation for PK studies in toxicology species
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Brief summary of bioanalytical methods for biological samples
- Detection and quantification limits (LLOQ, ULOQ)
- Validation data including accuracy, precision, selectivity, linearity
- Stability of analyte in biological samples (freeze-thaw, bench-top, long-term)
Expected Deliverables
- Bioanalytical method validation report
- Summary of method parameters and acceptance criteria
ICH Guidelines: M3(R2)
Source: ICH M3(R2)
References
Related Sections
Up to4.2.2 — Pharmacokinetics4.2.2.2 — 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
4.2.2.6 — PK Drug Interactions
Nonclinical PK drug interaction studies (CYP inhibition/induction)
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