Regulatory in vivo PK Studies

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
Researcher in protective lab gear

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

Learn more about the role of clearance in pharmacokinetics and drug design