What are the differences in study design between an AMS-enabled study, and a traditional study?
Essentially none. In both study types, the therapeutic dose of drug contains 14C. When the study is designed around AMS, the amount of 14C is much lower. In this respect, the studies are virtually the same. It is possible however to apply more innovative study designs around AMS technology. For example, more than one 14C dose can be given because the levels of radioactivity are trivial.
Is AMS technology acceptable to the regulatory authorities for these types of studies?
Yes, we have examples of marketed compounds which have used AMS data in regulatory submission.
Using very low levels of 14C, are there concerns surrounding contamination of samples in the clinic?
These studies can be classified as non-radioactive and can be carried out in areas not previously used for 14C studies. Xceleron has experience in conducting ADME studies in patients whilst at home.
Are there any restrictions in the samples types that can be analyzed by AMS?
No. Blood, plasma, urine, feces and tissues can all be measured by AMS. If the sample can be ethically obtained, we can measure it.
How would chromatographic profiles be produced?
Although there is currently no routinely available HPLC-AMS interface, it is nevertheless commmon practise to collect HPLC eluent as fractions and analyze by AMS off-line. Full chromatographic profiles can be generated in this way.
Phase 0 Microdosing
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