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Clinical Research Center

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

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

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

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

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