Xceleron Services

March 20, 2011

Accelerating The Drug Development Process

Xceleron’s clinical research services help pharmaceutical and biotechnology clients to accelerate the drug development process and de-risk later clinical trial phases.

Clinical research teams turn to us to help them choose the best drug candidates before entering the clinical stages of pharmaceutical development, as well as to complete their regulatory submissions cost effectively and to problem-solve pharmacokinetic issues throughout the drug development process.

De-risking Later Stages of Drug Development

Using the enabling technology of accelerator mass spectrometry (AMS), Xceleron can detect and quantitate tiny traces of 14C-labeled drug, allowing for innovative clinical designs and analytical solutions unlike any other approach.

  • Use our Phase0/Microdosing Services to select the best candidate prior to Phase I, or to answer key questions about your preclinical candidate
  • Use the exquisite sensitivity of the AMS technology to support Preclinical Analysis for biologics or high potency drugs
  • Gain human bioavailability data without needing formal intravenous (IV) formulation development using our IVPK Service
  • Use our Solution to MIST Service to gain low cost human metabolite profiling data with just incremental cost on a standard Phase I study.
  • Perform regulatory ADME/Mass Balance studies with vastly reduced manufacturing and toxicity/dosimetry regulatory requirements.

[pullquote]“The debate is over: AMS provides the route to better drug development paradigms / protocols.”
Dennis A. Smith, Pfizer Worldwide Research & Development[/pullquote]

Delivering Cost and Timeline Savings

The cost and drug development timeline savings from our approach can be considerable. Drug researchers can save up to one year in clinical development time by using our AMS approach for a mass balance/ADME study, for example.

>> Read this recent Bioanalysis commentary: Pfizer recommends AMS for better drug development paradigms/protocols.
>> Contact us if you need to address any of these issues in your drug development program.
  • Latest News

    Microdosing studies: a consideration on analytical technology choice

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  • What our clients are saying about us...

    "...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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