ОЗВУЧИТЬ

Research Services

Pre-Clinical Trials

Pirogov Russian National Research Medical University has extensive experience in preclinical studies of medicinal products for medical use; as well as contract research on laboratory animals or research whose object is man.

We conducts preclinical studies of original and generic drugs in compliance with the principles of Good Laboratory Practice (GLP), international and Russian standards.

List of studies that are performed by us includes studies of drugs safety and efficacy, analytical chemical researches, as well as development and adoption of hygienic standards.

SAFETY STUDY

Study of general toxicity

  • Acute toxicity
  • Sub-acute toxicity
  • Chronic toxicity

Study of specific toxicity

  • Reproductive toxicity
    • Study of the embryotropic action of chemical compounds, including drugs, on experimental animals (reproductive toxicity and genotoxicity).
    • Assessment of the female and male generative functions by integral and specific indicators in the experiment.
  • Immunotoxicity at single and course administration of test chemicals
  • Allergenicity
  • Mutagenicity

Toxicity assessment is carried out in accordance with the OECD protocols for the testing of chemicals, GOST standards, The guidelines for preclinical and clinical studies of drugs (A.N. Mironov, N.D. Bunatyan and others — M.: Grif and K, 2012).

EFFICACY STUDY

Discovery of new drugs by screening pharmacological activity

  • by type of biological target (molecular, cellular, etc.)
  • by type of screening panel: genetic, chemical
  • by spectrum of the screening panel: non-directional, directional
  • by purpose: search, optimization

Study of specific pharmacological activity of new chemical compounds and its dosage forms by modeling of pathological processes on laboratory animals

  • Assessment of the effects on the function of the cardiovascular system (blood pressure, ECG, heart rate)
  • Assessment of anti-inflammatory activity in various models of inflammation
  • Study of specific activity of antineoplastic drugs (allogeneic orthotopic model of rat brain tumor, mouse mammary adenocarcinoma, etc.)
  • Assessment of mechanism of drug action by modelling of contusion spinal cord injury in rats
  • Study of drugs and chemicals affecting the central nervous system
    • Study of anticonvulsant activity
    • Study of analgesic activity
    • Study of tranquilizing (anxiolytic) action
    • Study of nootropic effects of drugs
    • Study of antidepressant effects of potential drugs
    • Study of action of drugs for the treatment of cerebral circulation disorders
    • Study of effects of drugs for the treatment of multiple sclerosis
  • Assessment of mechanism of drug action on isolated organs
  • Noninvasive monitoring of organs by MRI
  • Luminescent cells and fluorescent probes imaging by SpectrumIVIS-CT system
  • Noninvasive monitoring of bones by CT

In vitro study of specific pharmacological activity of drugs

  • Study of mechanism of drug action on the expression of individual genes on cellular models and tissue biopsies by using the REAL-TIME PCR method
  • Assessment of antioxidant activity of drugs by chemiluminescense method
  • Immunohistochemical analysis of drug action on cellular signaling pathways
  • Assessment of the influence of drugs on the phagocytic activity of blood by using chemiluminescent method
  • Confocal laser scanning microscopy of cell cultures and sections under the influence of drugs
  • Study of the internalization (capture) and distribution of drugs and nanoparticles inside cells
  • Determination of cytotoxicity of compounds in cell cultures

Assessment of drug efficacy is conducted in compliance with the principles of Good Laboratory Practice (GLP).

ANALYTICAL СHEMICAL RESEARCHES
  • Development of methods for studying the pharmacokinetic properties of chemical compounds and drugs
  • Study of bioavailability and biodistribution of drugs and their metabolites
  • Highly sensitive quantitative analysis of drugs and their metabolites concentration in biological samples
  • Development / adaptation of analytical methods for the dissolution test and in vitro study of active ingredients release
  • Comparative dissolution kinetics test
  • Validation of analytical methods
  • Stability study of objects in conditions of natural storage and “accelerated” aging

Analytical Chemical researches are conducted in accordance with the principles of Good Laboratory Practice (GLP).

DEVELOPMENT AND ADOPTION OF HYGIENIC STANDARDS
  • Development and adoption of hygienic standards (safe reference levels of impact, maximum allowable concentration) of chemical and biological factors in the air of the working zone and atmospheric air of urban and rural settlements

Development and adoption of hygienic standards of chemical and biological factors is carried out in accordance with the Decree of the Chief Sanitary Inspector of the Russian Federation № 25 of February 13, 2018 and sanitary-epidemiological rules and regulations of the Russian Federation.

To select the best research (testing) center for the client's needs, send a description of the required research to the Office of Pre-Clinical and Clinical Trials via e-mail koroleva_nv@rsmu.ru.