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IPR-EE and its clinical sites focused on three types of clinical studies:
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Pharmacokinetics in special patient populations (e.g. patients with hepatic or renal impairment)
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Proof of concept studies
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Site management of additional three big centres for phase III clinical trials
1. Pharmacokinetics in special patient populations
Several publications have shown in the past that pharmacokinetics may differ between healthy subjects and
patients. Therefore IPR-EE focused fast recruitment of patients from the target population for
pharmacokinetic investigations. This includes also interaction studies. Patients from different therapeutic areas may serve as pharmacological modes to investigate the effect of
degenerative processes in the excretion organs on total body clearance. Most frequently used models are
patients with different degrees of hepatic or renal impairment. The IPR-EE clinical sites have access to a
large number of patients of this category (refer to table).
Table : Availability of patients with renal or hepatic impairment at the IPR-EE clinical sites
2. Proof of concept studies
One of the most critical points in drug development is the first proof of efficacy in the target population (proof
of concept). As far reaching decisions depend on these data, IPR-EE has set up an internal quality control
system to guarantee the highest possible quality standard. In addition those kind of studies can be conducted
under strictly controlled condition in the IPR-EE clinical sites which are exclusively used for the conduction of
clinical studies and with a well trained clinical team. Multi-centric recruitment guarantees fast and as planned recruitment of patients from different therapeutic areas
3. Site management of additional three big centres for phase III clinical trials
Besides the own IPR-EE clinical sites
IPR-EE is able to open four big centres for phase III clinical trials in the main therapeutic areas. These centres are located at Lvov, Ivanfrankovsk and Ternopol.