AMS Microdose studies

Microdosing offers the advantage of requiring significantly less pre-clinical safety data than a therapeutic dose Phase I study. However, because of the low doses required to ensure no chemical toxicity, ultrasensitive methods are needed for ensuring accurate measurements.

A microdose is defined as less than 1/100th of the dose of a test substance calculated (based on animal data) to yield a pharmacologic effect of the test substance with a maximum dose of <= 100micrograms. Accelerator mass spectrometry (AMS) is unquestionably the most sensitive analytical detector in vivo microdosing experiments. Vitalea Scientists have years of experience with in vivo kinetic studies at microdose levels using AMS.

In January of 2006, the FDA issued the Guidance for Industry and Reviewers on Exploratory IND studies. This guidance describes microdose-AMS studies as one of early phase I exploratory approaches that are consistent with regulatory requirements while maintaining needed human subject protection. To encourage early human data, the only preclinical requirement to support a single-dose microdose studies in humans is an extended single-dose toxicity studies in animals. According to the new FDA Guidance, "...exploratory IND studies present fewer potential risks than do traditional phase I studies. Such limited exploratory IND investigations in humans can be initiated with less preclinical support than is required by traditional IND studies."

For European regulatory on microdose studies, please view the EMEA position paper on non-clinical safety studies to support clinical trials with a single microdose.

Vitalea has formed partnerships with several well-established Clinical Facilities in Europe and in the US to meet your clinical needs.