Phase 1 enhancement
Xceleron works alongside leading
pharmaceutical and biotechnology
companies to meet the industry’s most
fundamental challenge: improving the
efficiency and cost-effectiveness of
drug development.
Xceleron uses 14C microtracers and
ultra-sensitive accelerator mass
spectrometry (AMS) in a powerful
combination to provide unique early
clinical insights into drug candidate
performance in humans.
Pharmaceutical companies have
exhibited great interest in the use of
innovative phase 1 clinical study designs
to quantify absolute bioavailability (and
other fundamental kinetic parameters)
and metabolite safety. Such studies have
been designed by Xceleron in a way that
adds a small increment to the existing
expense of a human safety study.
Using a 14C microtracer combined
with AMS allows absolute bioavailability
information to be generated from a study
design in which a sub-therapeutic
intravenous dose is administered
concomitantly with a therapeutic extravascular
dose. This ideal clinical study
design does not require IV toxicity data
or extensive formulation of the IV dose.
Metabolite safety has gained
prominence since the publication of FDA
and ICH guidelines in 2008 and 2009.
Xceleron has developed, in collaboration
with its clients, a unique approach that
provides a very cost-effective phase 1
metabolism screen. By pooling samples
across subjects and time-points to form
one sample for analysis, a human
metabolite profile is produced that can
be used to compare preclinical models.
Xceleron combines technical expertise
with vast drug development experience
and rigorous quality control procedures
to provide its partners with data they
can rely on. The company has developed
the most extensive and validated
quality infrastructure for the analysis
of 14C by AMS.
Pharmaceutical and biotechnology
customers have turned to Xceleron
to help them make better-informed
decisions throughout every stage of drug
development. Xceleron-generated data
has been used to support the marketing
applications of seven approved drugs,
and several others in late-stage testing.
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