Acting FDA Commissioner endorses microdosing

At the recent Global Pharma R&D Summit held in Anaheim, California, Andrew C. von Eschenbach, M.D. Acting Commissioner of the US FDA, when asked his opinion of Human Phase 0 microdose studies stated ‘Phase 0 studies are an extremely important mechanism to reduce risk for drug developers. I would encourage innovators to take more risk in exploring this approach’. He went further by adding ‘I think the cancer community in particular should be adopting Phase 0 studies’.

This active endorsement of Phase 0 studies by such a high ranking official at the FDA shows that the Agency is open for business to receive Exploratory IND applications to accelerate drug development.

As recently demonstrated by the publication of the results of the independent CREAM trial microdosing provides a valuable insight into the human pharmacokinetics (PK) of new drug candidates which can then be used to:

• Assist in the compound candidate selection process
• Help establish the likely pharmacological dose and thereby determine the first dose for the subsequent Phase I study
• Select the best animal species for long term toxicological studies from microdose metabolite profiling data
• Calculate the likely cost of goods when the drug goes into production

Working on the principle that ‘the best model for humans is human’, human microdosing, using Accelerator Mass Spectrometry, enables the introduction of sub-pharmacological doses of new drugs into man much earlier than ever before possible.

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