- Development and validation of bioanalytical methods for determining the concentration of active pharmaceutical ingredients (API) and their metabolites in various biological fluids and tissues (blood plasma, urine, etc.);
- Routine analysis of samples according to validated methods;
- Determination of pharmacokinetic parameters;
- Preparation of research reports in accordance with national and international requirements.
A set of in vitro studies in the ADMET category (absorption, partition, metabolism, excretion and toxicity) used in the modern global pharmaceutical industry to develop and improve new drug candidates at an early preclinical stage.
A wide range of in silico research in the field of chemoinformatics, hemogenomics and bioinformatics:
- Selection of various compounds according to structural or pharmacophore criteria from the composition of API registered in the world pharmacopoeias in accordance with the requirements of the task (customer).
- Selection of candidate molecules through virtual screening based on molecular docking and pharmacophore modeling.
- Evaluation of physicochemical properties based on computer calculations or experiment.
- Molecular dynamics calculations and conformation analysis of biomolecules.
- Identification of binding centers and construction of a pharmacophore model.
- Estimated assessment of specific pharmacological activity.
- Potential pharmacological profile using ADME-Tox tests.
- Definition a structure-activity link (QSAR) and a structure-property link (QSPR).
- Prediction in silico of API metabolism sites for cytochromes P450 (5 basic of human).
- Prediction in silico of API-induced changes in the gene expression profile (separately for protein and mRNA).
- Prediction in silico of API cytotoxicity for tumor and non-tumor cell lines.
- Prediction of in silico endotoxicity (acute toxicity) of LD50 based on QSAR analysis of toxicological effects of chemicals on model organisms (rats) at four types of administration (oral, intravenous, intraperitoneal, subcutaneous).
- Prediction in silico of exotoxicity (environmental toxicity) based on QSAR calculation for the following indicators: 96-hour golian (lat. Phoxinus) in 50% of lethal concentration, 48-hour daphnia magna (lat. Daphniamagna) in 50% of lethal concentration, Tetrahymena pyriformis in 50% of the concentration of growth inhibition and bioaccumulation factor.
POSSIBILITIES OF PRE-CLINICAL API RESEARCH
Physico-chemical properties.
- Determination of melting point (installation for determining the melting point of Buchi Melting Point B-545 (Buchi, Switzerland).
- Determination of dissolution in water, polar and non-polar solvents (kinetic and thermodynamic measurements with UV-Vis and HPLC quantitative detection of solutes).
- Analysis of chemical stability in aqueous buffer solutions at different pH values (kinetic and thermodynamic measurements with UV-Vis and HPLC quantitative detection of solutes).
- LogD / LogP lipophilicity study.
- Investigation of the dynamic viscosity and other rheological characteristics of liquid and pasty APIs (Programmable Rheometer Brookfield Model DV-III (Brookfield, UK)).
Metabolism of API in vitro
- Kinetic studies of the stability of API in human serum (with UV-Vis and HPLC quantitative detection of substances).
Specific pharmacological activity
- Kinetic studies of inhibition of human serum butyrylcholinesterase with determination of Ki and IC50 (with UV-Vis quantitative detection).
- Kinetic studies of acetylcholinesterase inhibition with determination of Ki and IC50 (with UV-Vis quantitative detection).
- Kinetic studies of 15-lipoxygenase inhibition with determination of Ki and IC50 (with UV-Vis quantitative detection).
- Kinetic studies of activation / inhibition of superoxide dismutase (SOD) with determination of Ki and IC50 (with UV-Vis quantitative detection).
- Study of inhibition of peroxidation of human plasma proteins (with UV-Vis quantitative detection).
- Study of inhibition of lipid peroxidation of human blood plasma (with UV-Vis quantitative detection).
- Investigation of inhibition of free radical formation in the chemical RedOx system based on auto-oxidation of adrenaline (with UV-Vis quantitative detection).
- In vitro study of the potential cardiotonic activity of API (with UV-Vis quantitative detection).
- Investigation of the photoprotective properties of API in different ranges of the UV spectrum (with UV-Vis quantitative detection).
POSSIBILITIES OF LABORATORY TECHNOLOGICAL AND BIOPHARMACEUTICAL RESEARCH OF MEDICINES
- Pharmacopoeial dissolution test for solid dosage forms (installation for studying the dissolution kinetics of Vankel VK7000, VR750D, VK8000 (Vankel, USA), followed by UV-Vis or HPLC quantitative detection).
- In vitro comparative studies to confirm the equivalence of drugs in solid dosage form of systemic action (installation to study the dissolution kinetics of Vankel VK7000, VR750D, VK8000 (Vankel, USA), followed by UV-Vis or HPLC quantitative detection).
- Pharmacopoeial disintegration Test for solid dosage forms (device for studying the degradation kinetics (PharmaTest, Germany), followed by UV-Vis or HPLC quantitative detection).
- Determination of weight, hardness, diameter and thickness of tablets.
- Study of dynamic viscosity and other rheological characteristics of ointments, pastes and gels (Programmable Rheometer Brookfield Model DV-III (Brookfield, UK)).
- Study of chemical compatibility and stability of API and excipients.
POSSIBILITIES OF TECHNOLOGICAL RESEARCH IN THE PRODUCTION OF MEDICINES
- Development of technology (chemical production schemes, technological schemes and technological regulations of production) of APIs and medicines in accordance with GMP requirements.
- Development of regulatory documentation of various levels for the production of APIs and medicines.
- Identification of risks to quality in the technological process of production of APIs and drugs.
