4.2.2 — Pharmacokinetics
Pharmacokinetics studies: analytical methods, ADME, PK drug interactions
Requirements by Phase
ADME — absorption, distribution, metabolism, excretion. These studies characterize how the drug moves through the body, how it's broken down, and how it's eliminated. Required before Phase 1, though the depth increases as you move through clinical development.
Key sections: Absorption and Metabolism data feed directly into your starting dose justification. PK Drug Interactions become critical if your drug is a CYP substrate or inhibitor.
Regfo extracts PK parameters from your study reports — Cmax, AUC, half-life, clearance — and checks whether your exposure data supports the proposed clinical dose.
References
Sections
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
Related Articles
Related Sections
Up toModule 4: Nonclinical Study ReportsPharmacology 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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