International regulators particularly from the EU, Japan and Australia are increasingly requesting absolute bioavailability data in Phase II and Phase III. Obtaining this data using the traditional cross-over clinical design can take up to a year and $1.5M to allow for IV toxicity evaluations, IV formulation development and GMP manufacture.
Xceleron’s IV tracer approach eliminates all of these hurdles by utilizing a planned Phase I study, delivering the data in just 3 additional months at a fraction of the cost of a traditional crossover approach.
Over 5 of the world’s top pharmaceutical companies have used Xceleron’s IVPK Services to generate absolute bioavailability data for their filing packages.
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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