Covance Expands Microdosing Capabilities

AMS Technology Cuts Time, Money From Drug Development

Princeton, NJ - Covance has expanded its microdosing capabilities for drug development clients worldwide by entering into a non-exclusive agreement to obtain ultra-sensitive analysis technology with U.K.-based Xceleron. This collaboration with Xceleron, developers of accelerated mass spectrometry (AMS) technology that detects molecules at unprecedented levels of sensitivity, is a logical move, according to Mary Westrick, PhD, Global Vice President and General Manager of Clinical Pharmacology at Covance.

"We recognize the value that AMS capabilities can offer, and we've seen increased interest from our clients," she said. "The FDA's Critical Path Initiative encourages pharmaceutical researchers to pursue innovative means of reducing the time needed to bring medicines to market. Microdose studies, using AMS technology, have the potential to do just that."

Microdosing studies the behavior of compounds in vivo through the administration of doses so low they are unlikely to produce whole-body effects, but high enough to observe pharmacokinetic effect. With its more sensitive analytic detection capabilities, AMS enables in vivo microdose studies by:

• Detecting very small, even nanogram, dosage
  
• Requiring only very small biological samples for specific biochemical separations
  
• Reducing overall radioisotope exposures, inventories, and waste streams
  
• Enabling prediction of accurate drug pharmacokinetics at physiologic dose levels

Prior to working with Xceleron, Covance's Honolulu clinical research team pioneered the first human pharmaceutical microdose study in the United States with the drug zidovudine (AZT). This study demonstrated the feasibility of microdose technology and the excellent correlation to known pharmacokinetics of this drug.

Industry analysts estimate that only one drug candidate out of 10,000 successfully passes all of the testing required to receive approval for commercialization. "Microdosing using AMS in a small-scale, preclinical setting will enable clients to get a very early sense of a drug's pharmacokinetic properties. It can help them choose the right compounds to move forward in their research, before investing a lot of time and money," said Dr. Westrick. "AMS technology is an exciting advance in research that may enable us to cut time and cost out of drug development, and expand our role as industry innovators."

SOURCE: Covance