Pharmacokinetics Assays

Pharmacokinetics (PK) is a crucial part of biopharmaceutical toxicology that deals with the identification and evaluation of the absorption, distribution, metabolism, and excretion (ADME) of biotherapeutics in the human body. PK assays are an essential early step in biotherapeutic development that assesses the safety and toxicology of a drug product. Prolytix offers robust PK assays to support preclinical and clinical phases, as well as CMC programs that help ensure that your large-molecule biotherapeutic reaches commercialization quickly and efficiently.

GLP/GCLP/CLIA-Compliant Pharmacokinetics (PK) Assays

Our team develops, validates, and conducts PK assays from our integrated GLP, GCLP, CLIA, and GMP bioanalytical facilities to support each phase of a biotherapeutic’s product lifecycle. Our testing facilities maintain an outstanding FDA and client inspection track record. Prolytix’s PK bioanalytical services include:

  • Determining drug exposure in the body over time using parameters to evaluate the ADME of the drug
  • Target analyte quantitation via:
    • ELISA
    • HPLC
    • Electrochemiluminescence (ECL)
  • In-vivo support available after sample collection
  • Full support of in-vitro studies
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