- Safety and pharmacokinetic studies

 - Bioequivalence

          (single and multiple dose)

 - Tolerability studies

 - Special population studies

          (renal, hepatic insufficiency, old age, menopausal

          women, diabetic, thyroid, endocrine etc.)

   CPU and PRS is specialized in performing high quality, well-controlled clinical pharmacology studies.
   In Hungary clinical pharmacology studies can be performed with the approval of the National Institute of Pharmacy (for Phase I-II. and all volunteers studies including bioequivalence studies) and of the Regional Ethical Committee. For Phase I-II. studies the National Institute of Pharmacy issues an approval after the Central National Ethical Committee gives its consent.
   CPU/PRS cooperates closely with specialized laboratories for pharmacokinetic analysis in Hungary or Germany working according to GLP.

 - Protocol design

 - Case Report Form design

 - Statistics

 - Expert Report writing

 - Investigator's Brochure writing

 - Patient studies (Clinical Studies)

 - Reprezentation before national authority

   CPU and PRS are used to plan a study (Protocol, CRF and all necessary documentation), submit for approval and then carry out the study. Clinical and Statistical Report writing is included.
   For bioequivalence studies blood samples are prepared and stored by trained staff. Samples are transported according to instruction of the Sponsors to an Analytical Laboratory.
   CPU and PRS often use the facilities of ACC Laboratories, Pfungstadt, Germany, this a an Analytical Laboratory specializing in clinical pharmacology.
   CPU and PRS has a biometric unit with the necessary traning and experience to performed biostatistical analysis of then studies.