Since the start of our CPRU (clinical pharmacology research unit) in the fall of 2004 we have conducted a series of interesting ‘on-line’ studies, where there was extensive collaboration between the clinical and the bioanalytical departments; the kind of projects that can only be conducted in facilities like Xendo’s, where bioanalytical and clinical facilities are fully integrated. A recent example is a bridging study for approval of a product that has already been marketed in Japan. For approval in Europe, several clinical studies with Caucasian human volunteers had to be repeated and Xendo was selected because of their dedicated facilities, i.e. bioanalytical laboratory and clinical pharmacology research unit under the same roof.

Lab and clinic under the same roof

The challenge was posed by the instability of the compound in human blood and urine. After blood is drawn, the concentration in human blood is reduced by 50% within two hours. Therefore a stabilizer had to be added directly after the blood was drawn, at the bedside, immediately after which the samples were transferred to the lab and extracted directly into organic solvent, which guarantees stability for at least 6 months (-20 °C).

To accomplish this logistics-wise complex task, laboratory staff had to be present at the bedside and in the laboratory 24 hours a day for 48 hours total (the total duration of blood sampling after dosing) during 4 study periods.

The final proof of the intense cooperation between lab and clinical staff was in the pudding, when it turned out that the generated bioanalytical PK-results (for parent and 2 metabolites) looked splendid. They demonstrated that Xendo has excellent facilities for the execution of complex studies that not only require a very close cooperation between clinical and bioanalytical staff, but also research facilities where the lab and the clinic are not too distant from each other. Another example of studies that require integration of bioanalytical and clinical pharmacology
research units will be given in a future news article (LPS challenge testing).