ABOUT US
Key areas of activity
- development and validation of analytical procedures for assay of drug substances and their metabolites in biological samples
- analysis of samples obtained during the clinical part of the study including incurred samples reanalysis;
- development of study design
- calculation of pharmacokinetic parameters, assessment of bioequivalence
- statistical analysis of data and preparation of reports about performed studies
- development of bioequivalence study protocols
Ample opportunities for performance of bioanalytical studies are provided by:
- high-technology instrumental basis
- experienced team
Validation of bioanalytical procedures is performed in accordance with the requirements of international and Russian regulatory documents. Full validation of analytical procedure includes the following tests:
- selectivity;
- evaluation of lower limit of quantitation, LLOQ;
- linearity;
- accuracy;
- precision;
- carry-over effect;
- matrix effect;
- recovery;
- dilution integrity;
- evaluation of minimal values of analyte and internal standard (IS) response;
- stability;
- back-conversion of metabolites, if applicable.
“Biotechnology” Laboratory uses a wide range of bioanalytical procedures, which were extensively tested in practice of bioequivalence studies.
| |
Bioequivalence studies, phase I clinical trials, validation of bioanalytical techniques, pharmacokinetic calculations, statistical analysis, consulting services
CONTACTS
Address:
Technopark building, Nazarbayev University, Kabanbay batyr dangyly 53, Astana 10 000, Kazakhstan
Phone:
+7 (717) 264−0849
Technopark building, Nazarbayev University, Kabanbay batyr dangyly 53, Astana 10 000, Kazakhstan
Phone:
+7 (717) 264−0849
