IVPK Studies in Phase II/III

April 18, 2011

Saving Cost and Time With IV Tracers and AMS

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.

>> Read more: Recent Applications of AMS in Metabolism and PK
>> Contact us to discuss how we can cut costs and timelines in your Phase II and Phase III clinical trials
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