SIVILAB®
PHARMACOKINETIC STUDIES AND BIOEQUIVALENCE
Pharmacokinetic
studies of large and
small molecules
SCIENCE INTELLIGENCE VERIFICATION INDEPENDENCE
SIVILAB® performs the analytical part of clinical and pre-clinical trials related to pharmacokinetics and bioequivalence studies.
There are significant differences between large and small molecules, therefore the pharmacokinetic profiles of biological drugs are very different from the small molecules. Absorption, distribution, metabolism, and excretion are very different between large and small molecules, which influences the pharmacokinetic profile of the drug.
Bioanalytical studies of high-molecular weight compounds (large molecules) are performed for qualitative and quantitative analysis of the biotechnological drugs, which are carried out in the natural biological media, such as serum and plasma.
A significant quantity of newly developed medicinal products related to large molecules include recombinant peptides and proteins, monoclonal antibodies and conjugates.
Bioassay of such molecules is generally performed by enzyme-immunoassay such as ELISA. Thanks to the variety of enzyme-immunoassay (ELISA) methods used in our laboratory, we can perform identification and assay of almost any bioanalyte.
In some cases, hybrid liquid chromatography andtandem mass spectrometry methods are also suitable, and experts in the SIVILAB® bioanalytical department can develop and validate mass spectrometry methods for large molecule analysis (LC-MS/MS).
A significant quantity of newly developed medicinal products related to large molecules include recombinant peptides and proteins, monoclonal antibodies and conjugates.
Bioassay of such molecules is generally performed by enzyme-immunoassay such as ELISA. Thanks to the variety of enzyme-immunoassay (ELISA) methods used in our laboratory, we can perform identification and assay of almost any bioanalyte.
In some cases, hybrid liquid chromatography andtandem mass spectrometry methods are also suitable, and experts in the SIVILAB® bioanalytical department can develop and validate mass spectrometry methods for large molecule analysis (LC-MS/MS).
For small molecule bioassay, we use the latest analytical complexes based on liquid chromatography and tandem mass spectrometry (LC-MS/MS) methods, with which we can perform target molecule assay in biological samples in a very wide range (from pg/ml to μg/ml).
High sensitivity of analytical equipment is critical for low molecular weight bioassay, so it’s important to choose a laboratory with high-tech equipment that provides for confident performance of drug substances and/or metabolites assay in a wide analytical range and fully complies with the requirements of regulatory documents for your PK study.
High sensitivity of analytical equipment is critical for low molecular weight bioassay, so it’s important to choose a laboratory with high-tech equipment that provides for confident performance of drug substances and/or metabolites assay in a wide analytical range and fully complies with the requirements of regulatory documents for your PK study.
SIVILAB® Scientific Research Center provides full support to a Client until the completion of the project.
Work on the project begins at the stage of developing a synopsis of the clinical study protocol. Our specialists prepare the sections of the Protocol devoted to the analytical method, offering the Client the most optimal option based on international literature data.
Assistance is provided in finding and purchasing internal (isotope-labeled) reference standards.
Laboratory instructions for working with blood samples are developed for the clinical center laboratory on a mandatory basis, and laboratory kits are provided if necessary.
If requested by a regulatory authority, SIVILAB® is fully responsible for responding promptly and preparing the necessary information required from the analytical laboratory upon request.
Assistance is provided in finding and purchasing internal (isotope-labeled) reference standards.
Laboratory instructions for working with blood samples are developed for the clinical center laboratory on a mandatory basis, and laboratory kits are provided if necessary.
If requested by a regulatory authority, SIVILAB® is fully responsible for responding promptly and preparing the necessary information required from the analytical laboratory upon request.
Each bioanalytical assay includes method validation with the following mandatory steps:
- Method selectivity evaluation.
- Method specificity evaluation.
- Evaluation of the influence of interfering substances in the biological sample (matrix effect).
- Evaluation of the linear range of the calibration curve.
- Accuracy and precision evaluation.
- Evaluation of stability and reproducibility of the measurements.
The main objective of bioequivalence studies is to perform quantitative determination of the substances under study in complex biological matrices such as whole blood, plasma, serum and other biological fluids.
- SIVILAB® has performed more than 300 bioequivalence studies of drugs.
- All bioanalytical studies are performed according to GLP standard (Certificate No. 24.0917.026 dated August 28, 2024).
- All reports are drawn up in accordance with Decision of the EEC Council No. 85 dated November 3, 2016 for further possible registration of the medicinal product in the EAEU countries.
- SIVILAB® regularly undergoes external Client audits of its QMS and work processes.
SIVILAB® uses the latest mass analysis instruments and continues to upgrade its instruments as new models and technologies become available.
We use automated approaches for rapid sample analysis: all analytical complexes are equipped with automatic plate changers that allow loading of up to 600 samples into the device and ensure uninterrupted round-the-clock operation during each analytical cycle.
All studies are performed under the guidance of highly experienced professionals using modern equipment capable of analyzing low-dose, hormonal and special category drugs with a lower limit of quantitation (LLOQ) up to 1 pg/ml.
During the planning and execution of the studies, as well as during the further preparation of the reports, our specialists follow a number of domestic and foreign guidelines:
- Decision of the EEC Council No. 85 dated November 3, 2016 “On Approval of the Rules for Conducting Bioequivalence Studies of Medicinal Products within the Eurasian Economic Union”.
- EMA Guidance Document – ICH M10 on bioanalytical method validation-2022.
- EMA and FDA Good Laboratory Practice (GLP) guidelines.
- FDA Guidance Document – Bioanalytical Method Validation-2018.
- FDA Guidance Document – M10 Bioanalytical Method Validation-2022.
The laboratory repository of SIVILAB® Scientific Research Center, where biosamples are stored, is equipped according to the GLP standard.
- Storage at a low t° (-20°C, -60°C and -80°C).
- Continuous monitoring of the temperature parameters with an independent warning system.
- Emergency standby power supply.
- Video surveillance.
If you have any questions, you can receive a consultation. Please fill in the form below
and send a request.
and send a request.
If you have any questions, you can receive a consultation. Please fill in the form below and send a request.
© 2024 SIVIlab
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Services
Contact Us
121205, Moscow, Skolkovo Technopark, Bolshoy Boulevard,
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
info@sivilab.ru
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
- +7 3952 550-330
info@sivilab.ru
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