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:
“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
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.
Please follow the links below to access publications written on IVPK Studies:
Pharmaron Acquires Majority Stake in SNBL CPC
"...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."
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