|ABX-CRO is one of the few contract research organisations with extensive experience to conduct phase I trials also with radiopharmaceuticals. Radiation safety issues, regulatory requirements and nuclide logistics need to be dealt with. As commercial phase I units are not equipped to handle radiopharmaceuticals, such trials need to be conducted in academic institutions. ABX-CRO has developed special expertise to fully implement GCP in an academic environment.
Compounds labelled with ß-emitting radionuclids like 131iodine, 90yttrium, or 186rhenium are developed as oncological therapeutics. Strictly defined entry criteria may require a multicentre setting to ensure timely recruitment. Our established specialist network ensures optimal conditions for your trial.
Gamma-emitter labelled for SPECT imaging or the positron emitting nuclides 11C and 18F used in positron emission tomography (PET) are used as diagnostics or research tools.
Diagnostic phase I trials involve complex instrumentation and special radiopharmaceutical expertise. We cooperate with leading PET centres in Euope, North America and Japan.
Phase I trials with non-labelled substances are conducted in ABX-CROs Phase I Unit, with state-of-the-art subject monitoring, and an excellently equipped bioanalytical unit.
|The clinical unit performs:
» Single/multiple dose pharmacokinetic studies
» First -in-man studies
» Drug/food interaction studies
» Behavioural and autonomic toxicity studies
» Pharmacodynamic studies assessing:
- Cognitive functions (Vienna Testsystem™)
- Pharmaco-EEG (Schwarzer™, Cateem™)
- Heart rate variability (chart™)
- Skin conductance responses (PowerLab™)
The bioanalytical laboratory is fully GLP certified by the local competent authority. Modern equipment and outstanding analytical expertise to develop new bioanalytical methodologies for structurally complex compounds allow us to successfully address even demanding problems at competitive rates.
» HPLC with ultraviolet, fluorescence,
electrochemical and MS/MS (API 3000 PE)
» Gas chromatography with FID, ECD, NPD
and MS/MS (Iontrap) detectors
» Solid phase extraction SPE with an
Abimed XL detector
» Automatic data management system
conforming to GLP