Pharmacokinetics of small molecules
Study of pharmacokinetic parameters of chemical preparations. The study is carried out by determining the concentrations of the active substance in biological fluid by HPLC-MS/MS using a validated method in accordance with the current regulatory requirements of the EAEU.
The laboratory has experience in conducting studies of both classical medicine and non-standard ones - combined and hybrid preparations, endogenous compounds and modified-release forms.
As part of pharmacokinetic studies, bio-samples 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 clinical studies
01
Pharmacokinetics of biotechnological preparations
02
Pharmacodynamics of biotechnological preparations
03
Immunogenicity of biotechnological preparations
04
Central laboratory (safety and efficacy parameters)
05
Statistical processing (BE, I, II, III phases)
06
Comparative Dissolution Kinetics Test (CDK)
07
Biowaiver
08
Preparation of laboratory kits for conducting clinical trials
09
Provision of specific reagents, consumables
See also
Preclinical studies
01
Conducting pharmacokinetic studies on animals
Clinical studies
02
Conducting bioequivalence studies and early phase clinical trials
Pharmaceutical analysis of medicines and dietary supplements
03
Development and validation of regulatory documentation methods: authenticity, quantitative content, dosing homogeneity, impurities, dissolution