Pharmacokinetics of biotechnological drugs
Study of pharmacokinetic parameters of biotechnological medicinal products within the framework of preclinical studies. The study is conducted by determining the concentrations of the active substance in biological fluid using enzyme immunoassay methods validated in accordance with the current regulatory requirements of the EAEU.
The laboratory has experience in conducting studies of low-molecular heparins, erythropoietins, insulins, and medicinal products created on the basis of monoclonal antibodies.
As part of pharmacokinetic studies, biosamples are stored at a temperature not exceeding -65 °C for two months after completion of the study, followed by disposal.
9
chromatograph mass spectrometers
that allow for high-precision determination of low-molecular compounds in biological samples
500+
research
on bioequivalence and pharmacokinetics of medicinal products implemented by the laboratory
ISO 9001
Management System
is certified for compliance with the standard of Good Laboratory Practice (GLP) principles
Other services within the scope of the direction preclinical studies