Tsakalidis Analysis & Testing

Contact Info

A. Tsakalidis Inc.

12, Tsamadou street
GR-18531 Piraeus

T. +30 210 41 75 865
F. +30 210 41 72 895
info@tsakalidislabs.gr
www.tsakalidislabs.gr
G.E.MI. No: 54730809000

Home page > Services > Analysis by Sector > Pharmaceuticals > Bioequivalence Studies

Bioequivalence StudiesPrice list

Since 1997, Tsakalidis Analysis&Testing Laboratories in cooperation with Contract Research Organizations (CRO) has completed a significant number of bioequivelence studies submitted and approved by the National Organization for Medicines.

Building on the experience of our laboratory in the techniques of chromatography with GC/MS and LC/MS/MS and the capability of our analysts in research and development, we have validated methods of analysis for a number of active substances, including the following :

- Amlodipine
- Atenolol
- Captopril
- Diltiazem
- Enalapril / Enalaprilate
- Flutamide
- Hydrochlorothiazide
- Lisinopril
- Nifedipine
- Nitrendipine
- Trimetazidine

The process we follow to conduct a bioequivalence study includes:

Preparation of the studies's protocol and submission to the National Ethics Committee for approval
Approval of the study from the Ethics Committee of the selected hospital
Selection of the group of volunteers, clinical controls and health insurance applied to them
Conduct of the clinical part of the study and collection of samples under the supervision of the responsible medical personnel
Analysis of samples in our laboratories based on the validated method of analysis
Statistical process(ANOVA) of the results and pharmacokinetic parameters AUC, Cmax, Tmax .Conclusions about the bioequivalence between the original and the copy
Submission of the final report and all the facts of the study to the National Organization for Medicines for approval.

The staff of our laboratory and our associates have the professionalism and the kwoledge needed to ensure the quality and the completion of your study within scheduled timetable.