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If accepted, your abstract will also be published in the online supplement to , two of the top-ranked journals in gastroenterology.
Advocates of the technology now focus on promoting the use of AMS to address specific problems where the added value is clear.
This article focuses on the new uses for C-14 compounds, factors impacting on their preparation and how C-14 custom labelling suppliers are responding to meet new demands.
While traditional drug metabolism studies continue to play a key role in understanding the pharmacokinetics, metabolism and ultimate fate of small molecules, new technology has opened the door to study compounds directly in man.
Such adverse data may impact on a drug’s future marketability and could lead to costly additional studies.
With increasing demand for quality C-14 compounds suitable for human studies, several of the leading custom labelling suppliers have invested in additional capacity, facilities, processes and analytical capability.
Carbon-14 remains the isotope of choice as a tracer being biologically equivalent to carbon-12, having a low background in the biosphere (1ppt: 1 atom in 1012) and importantly facilitating easy quantification.
Its soft -emission does not require shielding but is easily detectable allowing mass balance determination of the parent compound and importantly its metabolites (even of unknown structure) and gives good definition for autoradiography.
Recent FDA guidance on the safety testing of potentially toxic metabolites has provided another growth driver for C-14.egulatory authorities require that studies follow official guidance and meet statutory quality standards such as GLP, GCP and GMP.
When using a C-14 compound it is vitally important to ensure there are no impurities present that may give the appearance of persistent drug residues, lead to artefacts or spurious results.
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One consequence of an increasing demand from regulators for robust quantitative data on the behaviour of new drugs in man and for information on the fate of pharmaceuticals in the environment, has been an increase in demand for carbon-14 labelled compounds.
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