Module 4nonclinicalpharmacokineticsndaind

4.2.2 — Pharmacokinetics

Pharmacokinetics studies: analytical methods, ADME, PK drug interactions

Phase 1

required

Phase 2

required

Phase 3

required

NDA

required

Pharmacokinetics studies: analytical methods, ADME, PK drug interactions

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Source: ICH M3(R2); ICH S3A

References

Bioanalytical method development and validation for PK studies in toxicology species

Absorption studies including bioavailability, rate and extent of absorption

Tissue distribution studies including plasma protein binding and tissue uptake

In vitro and in vivo metabolism studies, metabolite identification and profiling

Mass balance and routes of excretion studies

Nonclinical PK drug interaction studies (CYP inhibition/induction)

Other PK studies not covered in sections 4.2.2.1-4.2.2.6

Pharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions

Acute toxicity studies in 2 species (rodent and non-rodent) to determine lethal dose and target organ toxicity

Repeat-dose toxicity studies with duration matching or exceeding planned clinical exposure. ICH M3(R2) Table 1 defines minimum durations.

Genotoxicity studies: in vitro (Ames, chromosomal aberration) and in vivo (micronucleus)

Carcinogenicity studies: long-term bioassay, short-term transgenic models, other studies

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