Absolute Bioavailability and IV Pharmacokinetics Services

Pharmaron’s ¹⁴C IV microtracer design delivers intravenous PK with absolute bioavailability data more quickly and economically than a traditional 2-period oral/IV cross-over design, as no IV toxicology data or GMP IV formulations are required. Our microtracer study design is also scientifically superior with no temporal effects since IV and oral plasma PK data are obtained from the same plasma samples from the same subjects at the same time.

Absolute bioavailability data are frequently required by the regulatory authorities for candidate drugs in Phase II and Phase III clinical trials. Pharmaron’s team can help our partners increase the efficiency of their early-phase clinical development programs by incorporating either:

• A ¹⁴C microtracer dose concomitant with the extra-vascular therapeutic dose to assess absolute bioavailability and IV pharmacokinetics in a planned Phase I SAD/MAD program
• An identical approach to the above, but incorporating a 2^nd cohort in the ¹⁴C human AME program to receive the ¹⁴C IV microtracer dose

In both cases, the majority of the clinical costs are already sunk into the regular part of the Phase I program, and dosing one of the SAD/MAD cohorts or adding a 2^nd cohort in the human metabolism study, only increases overall costs incrementally. This is the most cost-effective approach for early drug development with the additional benefit of de-risking your compound.