Clinical PK with Absolute Bioavailability

Regulatory authorities frequently request absolute bioavailability data in Phase II and Phase III. Clients also incorporate absolute bioavailability assessments into planned Phase I programs (SAD, MAD, Food Effect), which is the most cost-effective approach.

Pharmaron’s 14C IV microtracer protocol delivers these data more quickly and economically than a traditional 2-period oral/IV cross-over design, as no IV toxicology or GMP IV formulation are required. The microtracer study design is scientifically superior with no temporal effects, as IV and oral plasma data are obtained from the same plasma PK samples from the same subjects at the same timepoints.

Our expert team provides:

  • Clinical study design consultation (for healthy or patient volunteers)
  • Method development and validation (GCP) for fully quantitative LC+AMS assay for 14C radiolabelled parent compound
  • Method development and validation (GCP) for fully quantitative LC-MS/MS assay for non-radiolabelled parent compound
  • Quantitation of parent drug (radiolabelled and non-radiolabelled) in plasma (and in urine/feces if required)
  • Quantitation of total 14C by AMS in plasma (and in urine/feces if required) to assess degree of systemic metabolism
  • Metabolite analysis (metabolite profiling/identification) if required

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