Biowaiver
Conducting a comparative dissolution kinetics test, validation of the comparative dissolution kinetics test and biopharmaceutical solubility for the purpose of registration of medicinal products according to the BCS (biopharmaceutical classification system) according to the biowaiver.
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 clinical studies
01
Pharmacokinetics of small molecules
02
Pharmacokinetics of biotechnological drugs
03
Pharmacodynamics of biotechnological drugs
04
Immunogenicity of biotechnological drugs
05
Central laboratory (safety and efficacy parameters)
06
Statistical processing (BE, I, II, III phases)
07
Comparative Dissolution Kinetics Test (CDK)
08
Preparation of laboratory kits for conducting clinical trials
09
Provision of specific reagents, consumables