- The analytical equipment fleet of the laboratory increased to 3 liquid chromatography-mass spectrometers of the world’s leading manufacturers Agilent и Sciex.
- The laboratory has performed more than 30 analytical projects to analyze of biosamplesobtained in the course of clinical trials. Average turnaround time for analytics biosamples was 7 working days for protocols up to 1500 samples and 14 working days for protocols with sample volume within 4000 samples.
- The leading molecule in terms of the number of studies conducted was INN dabigatran etexilate. This year we carried out 4 analytical studies of this drug from different customers.The distinctive feature of these projects is not only a large sample size (about 10,000 samples within one study), but also high scientific intensity. science-intensive analytical methodology developed by us.
- Total number of analyzed laboratory samples plasma samples analyzed by the laboratory amounted to more than 135 thousand.
- The laboratory’s specialists developed and validated from scratch validated more than 35 methods, and the total number of analytical methods in the laboratory’s collection increased to 85 by the end of the year.
- More than 10 articles on the results of scientific work of the laboratory were published in peer-reviewed journals.
- The chemical-analytical laboratory has successfully passed more than 5 independent audits, which resulted in the integration of updated procedures as part of the organization’s unified quality management system.
- Established a separate area of laboratory activity for the comparative dissolution kinetics test of TSCR (including the “biowaiver“) in accordance with the requirements of the Eurasian Economic Union (EAEU) of the Eurasian Economic Union (EAEU) for conducting research medicinal products in in vitro.
Thank you to all our customers and colleagues for our partnership in 2023 and look forward to further fruitful cooperation in the coming year.
