We offer services in assessment of pharmacokinetics, bioavailability, and bioequivalence of pharmaceuticals with pharmacokinetic profiling and statistical analysis of data obtained in nonclinical and clinical sample tests.
We also offer services in carrying out a bioanalytical part of clinical studies, i.e. in vivo pharmacokinetics studies.
Bioequivalence is a degree of equivalence of pharmacokinetic properties of the generic and originator drug products. A bioequivalence study is essentially an assessment of the generic drug efficacy versus the originator. An assessment of bioequivalence is one of the most crucial steps in the generic drug registration.
To assess bioequivalence of the generic drug to the originator, a clinical trial is conducted where a group of volunteers receives the test drug and the comparator under the supervision of medical personnel. Then, biological samples are collected from the volunteers in accordance with the clinical trial schedule and sent to a bioanalytical laboratory that carries out the bioanalytical part of the study. The bioanalytical laboratory measures concentrations of drug substances and/or metabolites of the same in biological samples. Then, based on the data obtained, main pharmacokinetic parameters are calculated, obtained results are statistically processed, and bioequivalence of the study drugs is assessed.
Work stages to determine pharmacokinetics or bioequivalence of generic products
Analytical procedure development and validation
Recording and storage of samples
Analyte(s) assay in biological samples
Statistical data processing
SIVIlab has all the resources necessary to perform analytical and statistical parts of a study.
We develop and validate bioanalytical assays for new and generic drug products by using liquid chromatography with tandem mass spectrometry (LC-MS/MS) in various biological matrices. All bioanalytical procedures are validated in compliance with requirements of USFDA/EMEA/CHMP/EWP and the Ministry of Healthcare of the Russian Federation. Method accuracy and reproducibility is ensured by modern analytical techniques, high quality equipment, internal audits, and compliance with quality management standards.
The laboratory archive is equipped as per GLP requirements.
Constant temperature monitoring is carried out by means of a non-volatile alert system with an option of instant mobile notifications.
0 to -20°C
Sample storage temperature
-20 to -40°C
Frozen sample storage temperature
Deep-frozen sample storage temperature
Samples are prepared by qualified personnel with the use of high-precision special-purpose laboratory equipment from manufacturers widely recognized in laboratory practice: Mettler Toledo, Thermo Scientific, Sanyo, Spark, and others.
The analyte(s) assay in biological samples is calculated by using modern analytical systems based on high-performance liquid chromatography and tandem mass spectrometry:
All analytical systems are further equipped with Shimadzu RACK CHANGER II units which enables round-the-clock testing of samples. The analytical system based on the Shimadzu LCMS 8050 mass spectrometer is further equipped with an online solid phase extraction system by Spark SYMBIOSIS.