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Drug Research Unit Gent
> D.R.U.G.'s Research
 
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  1. Scope of Research
  2. Study Conduct
  3. Study Experience

 

D.R.U.G.'s Research

  1. Scope of Research
  2. Study Conduct
  3. Study Expertise

1. Scope of Research

D.R.U.G. conducts phase 0, I and II clinical trials.

For the Phase 0 and Phase I trials, D.R.U.G. has a database with more than 2.000 volunteers willing to participate in clinical trials.

Phase II trials are conducted in cooperation with other departments of the University Hospital Ghent.


2. Study Conduct

D.R.U.G. conducts its clinical trials according to Good Clinical Practice and local, European and international legislation. Besides, the quality management system of D.R.U.G. complies with NBN and ISO 9001:2008.


3. Study Experience

D.R.U.G. is experienced with following types of studies:

  • Biomarker
  • First in Human: single and multiple dosing (dose-escalation)
  • PK & PD studies
  • Relative and absolute bio-availability
  • Interaction studies (drug-drug and food-drug)
  • Efficacy and safety (Phase II)
  • Early clinical trial assessment (ECTA)

D.R.U.G. takes advantage of knowledge and facilities present in other departments of the University Hospital Ghent (e.g. Department of Gastroenterology, Gynaecology, Neurology, Radiology, Emergency Services, ...)