Bioanalysis

Renovation of Bioanalytical Radiochemistry Laboratory Attached to Phase I Unit in the Netherlands Facilitates Top-Tier Human Mass Balance Studies

This summer, the Phase I and bioanalytical facilities of QPS in the Netherlands have completely renovated their radiochemistry laboratory. The laboratory, which is attached to the clinical facility, enacts human mass balance (HMB) studies with online analysis of excretion samples for quick counting, thereby ensuring dismissal of volunteers immediately upon recovery of the dosed activity. In addition to analyzing biological samples for radioactivity by liquid-scintillation or gamma counting, the laboratory can also perform analysis and confirmation of the dosed activity using HPLC with radio-flow detection.

Both laboratory and clinic are fully licensed to execute HMB studies. The clinic also possesses experienced microdosing capabilities. And, as always, QPS Netherlands’ Phase I unit benefits from the Netherlands’ streamlined regulatory procedures: protocols are submitted to the ethics committee and the competent authority simultaneously. The CTA is obtained within 14 days, without the involvement of a radiation board. Hence, approval is obtained from the IRB within 4 weeks of protocol submission.

Beyond mass-balance studies, in support of regulatory submissions, QPS provides ADME services to investigate the total fate of radiolabeled drug candidates, characterizing the route and rate of excretion, tissue distribution, metabolic pathways, and identity and quantity of metabolites.

dose-excreted
Extension with Preclinical Development

QPS is a true turnkey ADME study provider: we can also effectively execute your radiolabeled studies in preclinical development. By placing your preclinical as well as your clinical ADME studies with QPS, you will benefit from peer-to-peer communication between and with our ADME scientists, enabling optimal study planning and execution. The experience and data generated during preclinical development will speed up your clinical phase, thereby saving time and cost by avoiding repetition.

Author

QPS Netherlands
JaapWieling, Ph.D., Sr. Vice-President, Bioanalysis& Technology R&D
jaap.wieling@qps.com

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