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Xceleron welcomes FDA's draft guidance on microdosing
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Exploratory INDs will enable reduced drug development time and costs |
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Additional Information
Xceleron welcomes publication by The Center for Drug Evaluation and Research (CDER) at the FDA of a draft guidance document on "Exploratory IND Studies"[1] presenting its views on a more flexible approach to early Phase I clinical studies.
Observing the detailed references to human microdosing in the publication by the CDER, Professor Colin Garner, CEO of Xceleron said that such an approach "could significantly reduce the time and resources spent during early drug development. This is a great boost and vote of confidence in innovative new techniques such as microdosing that can help pharmaceutical companies to develop products faster and more efficiently. The report further endorses our belief in ultra-sensitive Accelerator Mass Spectrometry as the enabling technology for human microdosing studies."
The concept of human microdosing is specifically mentioned as an example of the type of study that falls within the Exploratory IND. Using exquisitely sensitive analytical technologies to track them, sub-pharmacological doses of new drugs can be given to humans at a very early stage in the drug development process. This allows human information to be determined much earlier than ever before possible, providing drug developers with a means to progress only the most promising drug candidates to further, more expensive clinical trials.
The document defines a microdose as 1/100th of the dose calculated to yield a pharmacological effect with a maximum dose of 100 micrograms, as per the EMEA's position paper of June 2004. However, it differs from the EMEA paper in that no genetic toxicology tests are required, reflecting the fact that these studies are safe for human subjects at these microdose levels.
The Exploratory IND and its implications for human microdosing studies will be amongst the manu topics to be reviewed at a conference co-sponsored by Xceleron and CDDS entitled "Optimizing Drug Development For Success" to be held in London on the 15/16th June 2005.
For the agenda for "Optimizing Drug Development For Success" click on this link
Optimizing drug development for sucess pdf
To read the draft guidance Exploratory IND document click on this link
Exploratory IND document pdf
[1] Guidance for Industry, Investigators and Reviewers. Exploratory IND Studies Draft Guidance. Center for Drug Evaluation and Research, Food and Drug Administration. US Department of Health and Human Services. April 2005
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