March 30, 2011

Xceleron’s IVPK studies deliver the optimal clinical design for deriving absolute bioavailability data, eliminating the cost and variables associated with the traditional crossover design.

Our IV PK solution can be applied very cost effectively in early clinical and exploratory development as well as in Phase II and Phase III clinical trials. These data are particularly useful for the following groups:

  • Clinical Pharmacologists
  • Formulation Scientists
  • Regulatory


“Concomitant administration…is an application of the AMS technique that produces better quality data on a very important drug characteristic, does not require any extra synthesis and probably saves overall cost.” – Dennis Smith, Pfizer


Benefits to Clinical Pharmacologists

  • Gives the fundamental pharmacokinetic data, including Clearance, Volume of Distribution and Absolute Bioavailability.
  • These data fully describe the disposition profile within the body.
  • Effects of absorption and elimination on plasma half life can be distinguished.

Benefits to Formulation Scientists

  • Understand how absorption and elimination each contribute to the PK profile.
  • In conjunction with an oral 14C dose, distinguish the effects of absorption and first pass metabolism.
  • Determine the peak bioavailability to benchmark against future formulations.
  • Calibrate bioequivalence in terms of absolute bioavailability.

Benefits to Regulatory

  • Regulatory authorities particularly in Europe, Australia and Japan are placing increasing emphasis on absolute bioavailability data.

Our approach involves administering a 14C-labeled tracer dose intravenously (IV) with an extravascular (oral, dermal, inhaled etc) dose given at a therapeutic dose level. The IV dose is given contemporaneously with the estimated Tmax of the extravascular dose. The IV dose is so small that it does not disrupt the extravascular dose. As a result, there are no issues regarding scaling.

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