Finally, tests on biological samples are already underway in Armenia!

 

The 1st internationally accredited analytical laboratory, "FDA Laboratory" LLC, conducts tests of biological samples of drugs.

 

The development and validation of bioanalytical methods for the quantitative determination of drugs in biological samples is carried out in the laboratory, in accordance with the current recommendations and regulations, using the LC-MS/MS method.

 

The results are carefully processed by a highly trained analytical chemist who confirms the correctness of the analysis through several quality control measures (accuracy, precision, spiking, etc.).

 

Analysis of the concentration of drugs in biological samples at the FDALab analytical center is carried out in accordance with:

 

• EAEU: (Appendix No. 6) to the Rules for Bioequivalence Studies of Medicinal Products within the EAEU.
• ICH Guideline: ICH guideline M10 on bioanalytical method validation study sample analysis, and Bioanalytical method validation USFDA.
• International Accreditation: The activity of the laboratory is confirmed by international accreditation in accordance with the requirements of ISO/IEC 17025:2017 (GOST ISO/IEC 17025-2019) "General requirements for the competence of testing and calibration laboratories”.

 

More detailed information on the development and validation of bioanalytical methods for the quantitative determination of drugs in biological samples can be found here.