in vivo PK Using Radiolabelled Compounds
in vivo PK Using Radiolabelled Compounds Services
Pharmaron provides a comprehensive portfolio of services employing 14C and 3H radioisotopes to study the metabolism, PK and disposition of compounds in non-clinical and clinical development for both small and large molecules. We are unique in offering AMS in conjunction with LSC, in stand-alone and ‘hybrid’ study designs. Pharmaron offers end-to-end solutions from radiosynthesis to non-clinical to clinical. This assists our partners to design and execute a complete metabolism strategy to meet all the desired endpoints for each specific molecule.
Pharmacology models used with 14C/ 3H radiolabels include oncology, CNS, pain, metabolic diseases and inflammation.
Capabilities
in vivo PK Capabilities
- Integrated services with 14C and 3H radiosynthesis
- Single dose, repeat dose and cassette dose studies
- Dose routes include PO, IV, IP, SC, IT, IM, IN
- Wide range of species and animal models
- Total radioactivity analysis by LSC and/or AMS for mass balance, routes and rates of excretion
- Parent analysis by LC-MS/MS and/or LC-AMS
- Metabolite analysis and structure elucidation (met profiling & MetID)
- PK parameters and PK analysis
Radiosynthesis
- Standard 14C and 3H radiosynthesis to provide radiolabels for non-clinical ADME
- GMP preparation of 14C-drug substance and 14C-drug product for clinical ADME
- Non-GMP clinical-grade re-purification of 14C-drug substance for AMS-enabled human microtracer studies
- 14C and 3H radiolabelling of large molecules and biologics e.g. oligonucleotides, peptides, proteins
- Expert metabolism and biotransformation advice for positioning the radiolabel so that it is in a metabolically stable part of the molecule
