The staff and facilities of CPU and PRS are shared. Well known and experienced scientists (US and Hungarien) are members of the Scientific Advisory Board of both organisations.
   There is an independent Quality Assurence Unit responsible to the director of the I. Dept. of Medicine.
    The CPU has complete access to the facilities and staff of the Medical and Health Science Center, University of Debrecen, which is the largest Regional Medical Center (hospital and out patient clinics) in the eastern part ofr Hungary.


 

THE BIOEQUIVALENCE STUDIES PERFORMED
IN 1997-2000 BY CPU AND PRS LTD.

 

Test and reference drug

Number of Volunteers

1.

Alpha D3 v. Alfa-D3

36

2.

Naproxen v. Naprosyn

24

3.

Pentoxifillyn 600 mg v. Trental 600 mg

24

4.

Enalapril 5 mg v. Innovace 5 mg

24

5.

Enalapril 20 mg v. Innovace 20 mg

26

6.

Famotidine 20 mg v. Pepcidin 20 mg

24

7.

Famotidine 40 mg v. Pepcidin 40 mg

24

8.

Omeprazole 40 mg v. Antra 40 mg

28

9.

Mephaquin v. Lariam

32

10.

Diltiazem v. Dilatam

60

11.

Morphine v. MST Continus

24

12.

Trialkim I. v. Trisequens I.

26

13.

Trialkim II. v. Trisequens II.

26

14.

Verapamil 40 mg v. Isoptin 40 mg

24

15.

Verapamil 80 mg v. Isoptin 80 mg

24

16.

Mephaquin v. Mephaquin formulation v. Lariam

32

17.

Captopril/Hydrochlorothiazide 50/25 mg v. Capozide

30

18.

Captopril/Hydrochlorothiazide 25/25 mg v. Capozide

30

19.

Fluvoxamine v. Floxyfar 100 mg

30

20.

Loratadine v. Claritine

48

21.

Diamox v. Diazomid

26

22.

Gefulvin v. Griseofulvin

28

23.

Clemastine v. Tavegyl

31

24.

Mephaquine v. Lariam

40

25.

Propranolol v. Inderal

28

26.

Simvastatin v. Zocor

36

 

   The results of these studies were used for submission to registration authorities in Hungary and all over the world.
   Up to now all our report on studies performed by PRS and CPU have always been accepted by any registration authority. This is a 100% score. We consider this an acknowledgement of the quality of our work.