A sensitive and reliable assay is essential for the preclinical development of a candidate IMP, so a suitable method is almost always in place before the start of first-in-human trials. However, sponsors sometimes wish to transfer an assay method to a new laboratory in the UK, in which case we’re happy to nominate external laboratories that we know from our experience can do an excellent job within demanding time limits.
The HMR Laboratory regularly assays concentrations of carbon-14-labelled drugs, not only in biological samples from Absorption, Distribution, Metabolism and Elimination (ADME) trials but also as part of the verification of carbon-14 content of sterile and non-sterile solutions of radiolabelled IMP for administration to trial subjects.
Other services offered in-house include
- Gas chromatography
- Drugs of abuse