Phase I trials

We have an extensive experience with designing Phase I trials with psychotropic compounds (mainly anxiolytics and antipsychotics) and antiparkinsonian drugs. We have monitored Phase I trials with symptomatic volunteers (e.g. hepatic failure).

We collaborate with Clinical Pharmacology Unit, in a teaching hospital located in Prague. This unit specializes in providing studies in early phases of the development of Medicinal Products and Medical Devices. The Unit has a capacity of 28 beds with standard equipment to provide pharmacokinetic & bioequivalence studies, as well as phase I, I/II studies. CPU has been inspected by the Regulatory Authority (State Institute for Drugs Control) in 2009 and found to be compliant with GCP standards. The CPU is also certified to provide drug and device studies phase I-IV under ISO 9001/2008 (2010).

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