In preparation for the initiation of their Phase I clinical trial, a biopharmaceutical company contacted MicroConstants to develop and validate a bioanalytical method for their study. They also requested that we provide specimen collection kits to the clinical site conducting the trial and perform bioanalytical and pharmacokinetic analysis on the samples collected.
During method development we discovered that our Client’s drug had labile metabolites that would readily hydrolyze back into the parent compound and potentially lead to an over-estimation of drug levels. Phosphoric acid stabilization was necessary to prevent this conversion in plasma, but the addition would complicate the collection process for the clinical site conducting the Phase I study.
To simplify the collection of plasma samples, we assembled customized specimen collection kits containing a calibrated fixed volume pipette and cryotubes which we would pre-aliquot phosphoric acid into prior to shipment. Distributing clinical kits with these collection supplies to the site ensured that each of the study samples would contain the appropriate ratio of acid to plasma, circumventing possible stability issues during sample collection, storage, and analysis. The kits also included additional collection supplies, labels, shipping materials, and a detailed sampling, handling, and shipping manual that we generated based on the study protocol.
We remained in contact with the clinical site throughout the duration of the study, helped coordinate all shipments from the site back to MicroConstants for sample analysis, and replenished kit supplies as needed. Every five months, we shipped a replacement pipette to the clinical site so the fixed volume pipette would not exceed calibration timelines (re-calibration for pipettes provided with kits is required every six months per our Standard Operating Procedures).
Providing clinical kits tailored specifically to our Client’s sampling needs helped streamline their Phase I trial and ensured that all specimens collected by the clinical site were stabilized, properly labeled, and provided accurate pharmacokinetic data.