 Phase I and Phase IV studies are conducted
and monitored by experienced research personnel in the 24-bed
General Clinical Research Center. CADD capabilities include:
bioavailability, bioequivalence, pharmacokinetic, pharmacodynamic,
safety, tolerance, drug interaction, gastrointestinal absorption
and first time use in human studies.
Phase
II and III studies are coordinated within The University of Iowa
Hospitals and Clinics. Outpatient studies involving new chemical
entities, clinical efficacy and safety evaluations, dose ranging,
over-the-counter (OTC) medications, prescription to OTC switch,
new dosage forms and new and reformulations of existing products
are performed using a large population of symtomatic and healthy
volunteers.
Other
services include protocol writing, analysis of biological samples
for drugs and metabolites staistical analysis and reporting and
medical writing services to produce integrated clinical and statistical
summaries. |
