Regulatory in vivo PK Studies

Pharmaron offers in vivo PK, toxicokinetics (TK), and formulation analysis services to support preclinical development for small molecules, peptides, nucleosides/nucleotides, and biologics. All in-life work of PK/TK studies is conducted in AAALAC-accredited animal facilities and follows IACUC-approved study protocols.

Filing in vivo PK Studies

Single and repeated-dosing PK studies on rodent and non-rodent test systems
Mass balance and tissue distribution
in vivo metabolite identification/analysis
Bridging PK studies

Capabilities

Regulatory in vitro ADMET Studies

Regulatory in vivo PK Studies

Download our Pharmacokinetic service overview

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Absorption

Single dose PK (FDA: 3M or 3F, 1 dose, NMPA: 3M+3F, 3 doses, Exposure-dose relationship)
Repeated dose PK

Distribution

3M+3F, at least 3 time points
Reference for target organs nomination in toxicity evaluation

Excretion

Urine, feces, bile
If low recovery, in vivo met ID and/or mass balance (hot compound) is recommended

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