Microdosing

The selection of candidate drugs to take forward to full clinical development can be greatly facilitated by human pharmacokinetic (PK) data. These data help to identify potential development issues prior to embarking on Phase I and help to guide decision making on further clinical development strategies.

By giving a sub-therapeutic ¹⁴C-radiolabelled dose of a candidate drug, human PK data can be obtained without the extensive regulatory and manufacturing requirements associated with the administration of pharmacological dose levels. The microdose study approach, typically applied in a simple study design involving 4-6 volunteers per compound, results in very low radiation doses.  Quantification relies on the use of ¹⁴C-radiolabelled API and subsequent analysis by accelerator mass spectrometry.

Quotient Clinical is a leading exponent of “Phase 0” microdose studies having performed studies involving various different routes of administration and covering products from many therapeutic areas.  A critical component in the organsisation of these studies is to ensure that the study will generate optimal data to inform the candidate selection process.  At the development stage of the study synopsis and protocol we engage our medical and scientific experts with their counterparts at the client company to ensure the agreed study design will meet the desired objectives and will address the necessary ICH and regulatory guidelines.

For details on performing a Phase 0 microdose study with Quotient refer to our Factsheet.