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Clinical Pharmacology and Pharmacoepidemiology

Clinical Research Center

 

Staff

Head:

Prof. Gerd Mikus, MD, MSc

Scientific staff:

Antje Blank, MD
Verena Hafner, MD
Sonja König, Doctor
Christoph Markert, MD

Visiting scientist:

Sybille Baumann, MD

Study assistant:

Marlies Stützle-Schnetz

Study nurse:

Brigitte Tayrouz

Doctoral students:           

Stephanie Katzenmaier
Ines Fuchs
Ulrike Merkel
Isabel Wustrow
Victoria Ziesenitz

Current projects

  1. K084: Pharmacokinetics of intravenous voriconazole and its excipient SBECD in patients receiving haemodialysis, haemodiafiltration, or Genius-dialysis (multicenter).
  2. K093: Genotype screening of volunteers for the participation in clinical studies.
  3. K106: AOP101 (first in man study) (Cooperation with Innere Medizin V).
  4. K119: Evaluation and validation of a 5-drug cocktail for phenotyping of CYP1A2, CYP2C9, CYP2C19. CYP2D6, CYP3A4, NAT-2, and xanthine oxidase.
  5. K171: Enterohepatic circulation of THCCOOH (Cooperation with Institute of Legal Medicine).
  6. K145: Pharmacodynamic interaction of a novel NO independent activator of sGC and glyceroltrinitrate.
  7. K155: Monocenter, open study on the pharmacokinetics of efavirenz: Assessment of induction of CYP3A4 and CYP2B6 as well as auto-inductive effects.

Equipment

  • 12 beds
  • 2 out-patient rooms
  • dayroom for test persons / patients
  • Mortara monitoring system at each bed connected to a central processing and reviewing unit
  • 12-lead ECG
  • non-invasive blood pressure measurements
  • pO2 measurements
  • invasive blood pressure monitoring (3 beds)
  • hand vein compliance measuring technique
  • cold-pressure-test
  • laser-doppler-flow
  • establishment, validation and application of new phenotyping models
  • rooms for sample processing, drug storage, sample storage
  • RNA-extraction
  • reanimation team
  • volunteer database

Operation

  • Standard Operation Procedures (SOPs) for equipment and activities
  • Database system for managing personal data of test persons, generating codes for samples, and printing their labels
  • Study Builder software
  • pharmacokinetic analysis with WinNonlin (Pharsight)
  • MEMS™ Compliance-Monitoring
  • Drug storage facilities at +4°C and +18°C
  • Sample storage facilities at -20°C or -80°C

 

Products / Services

  • Preparation of investigation schedules and CRFs
  • Organisation of Phase I-II trials, bioequivalence trials, pharmacokinetic and pharmacodynamic analyses
  • Preparation of final reports

Cooperations


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