Drug development teams turn to us for Phase 0 microdosing studies when they need to confidently select the most promising compounds for full drug development, or to confirm whether their compound reaches its target site of action.
Phase 0 clinical trials deliver definitive human PK data on which to base important decisions about compound selection or whether or not to proceed with ongoing clinical development. Our clients have used them to successfully leverage further financial investment and to support licensing discussions.
In microdosing studies, the dose administered is very small; typically 1/100th of the predicted pharmacologic dose to a maximum of 100 μg*. At Xceleron, we are able to detect such minute drug traces in the blood, tissue and body fluids using AMS analysis.
[pullquote]”Xceleron have pioneered the human Phase 0 Microdose approach [enabling] us to see the potential utility of AMS in improving our drug selection procedures.”
Dr Bernard Marchand, Servier[/pullquote]
Because these small doses are inherently safer than pharmacologically active doses, regulatory authorities accept a much reduced safety toxicology package.
Consequently, Phase 0 clinical trials can allow drug developers to obtain definitive human data earlier and with less expenditure compared to a Phase I clinical study.
* As defined by both EMEA and FDA. See Exploratory IND Studies Guidance For Industry.
Pharmaron Acquires Majority Stake in SNBL CPC
"...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."
Find out how we can help you accelerate your drug-development program.