Early Phase
Pharmacokinetic
GCTRO provides Pharmacokinetic (PK) services to monitor and analyze how the body absorbs – and how long it retains – drugs after they are administered. This is a critical data in enabling clients to decide on continuation of the study. We work with clients to proactively develop a PK strategy as an integral part of the drug development plan and design clinical studies in order to address specific PK objectives.
We have carried out over 60 such studies. Many of our studies have included specific specimen collection for further research. Hawaii Clinical Research Center has strong capabilities in this area. We have a -70° freezer for storage, refrigerated centrifuge and contracts with many couriers’ services to provide direct shipment of these specimens while maintaining their integrity.
Other studies have focused on safety and efficacy and pharmacokinetic sampling done at multiple time points. Inpatient stays have lasted as long as fifteen days in duration.
Among the PK studies we’ve done successfully are:
ADME
Bioavailability/Bioequivalence
Single ascending dose (SAD)
Multiple ascending dose (MAD)
Drug-drug interaction
Food interaction
Biomarker and Genotyping
