Preclinical studies

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Complex of services for the conduct of preclinical studies of drugs and medical supplies using cellular and tissue technologies (in vitro)

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Development of a preclinical study protocol
Evaluation of the intensity of cell division in vitro by the activity of cell respiration using methyltetrazolium (MTT) test (for insulin)
Determination of authenticity and purity by Western blot
Determination of authenticity, purity and molecular weight of genetically engineered drugs by the method of vertical polyacrylamide gel with sodium dodecyl sulfate
Study of the genotoxic of its medicinal compounds in vitro by the method of alkaline gel electrophoresis of isolated cells (DNA comet method)
Determination of LC50 (average lethal dose) for cell cultures by the MTT test
Determination of the mutagenic properties of medicinal compounds using the Ames test

Preclinical studies security , including:

Acute toxicity study (1 route of administration, 2 genders) , GLP

Comparative Acute Toxicity Study 
2 substances (1 route of administration, 1 floor) , GLP

And a study of acute toxicity (test No. 402, skin application ), GLP OECD

Acute toxicity study (test No. 420 , intragastric administration ), GLP OECD

Acute toxicity study (test No. 42 3 , intragastric administration), GLP OECD

Cumulation Study (1st floor) , GLP

Multiple dose toxicity study (duration of administration - up to 2 weeks ) , GLP

Multiple dose toxicity study ( up to 1 month for administration ) , GLP

Toxicity study with repeated administration (duration of administration - up to 3 months, 1 floor) , GLP

Toxicity study with repeated administration of an object (the duration of administration is up to 
6 months, 1 sex, rats) , GLP

Toxicity study with repeated administration of the object ( test No. 4 07 , 21/28-day intragastric administration ) , GLP OECD

Toxicity study with repeated administration of the object (test No. 410, 21/28-day skin application), GLP OECD

Comparative toxicity study with repeated administration of 2 substances (duration of administration - up to 2 weeks¸1 sex) , GLP

Comparative toxicity study with repeated administration of 2 substances (duration of administration is up to 1 month, 1 gender) , GLP

Research on reproductive (generative) toxicity in males (rats, 48 ​​days old) , GLP

Reproductive toxicity study in females (rats, 15-day administration) , GLP

Reproductive toxicity study (Embree about - and foetotoxic action is logged in the antenatal period of development, the female rats, 19-day administration), GLP

Reproductive toxicity study (Embry about - and foetotoxic effects recorded in the postnatal development of the female rats), GLP

Mutagenicity test ( Ames test ) , GLP

Mutagenicity test ( micronucleus test)

The study of allergenic properties (active skin anaphylaxis, guinea pigs) , GLP

The study of allergenic properties (1 test out of the series: delayed-type hypersensitivity reaction, inflammation response to concanavalin A , mice, 1-fold administration) , GLP

The study of immunotoxicity (effect on humoral immunity in the test for determining the number of antibody-forming cells in the spleen, mouse, 
1-fold introduction) , GLP

The study of immunotoxicity (effect on humoral immunity in the test for determining the number of antibody-forming cells in the spleen, mouse, 
28-day introduction) , GLP

Immunotoxicity study (1 test out of the series: effect on cellular immunity, phagocytosis, 
1-fold introduction) , GLP

The study of the immunogenicity of a biological drug , GLP

And pharmacological safety esearch - the impact of the drug on the vital systems of the body function (1 system from the series: the cardiovascular system, central nervous system, respiratory system and th), GLP

Acute toxicity
14 days subchronic toxicity
In vivo micronuclear test
Reproductive toxicity
Impact on the generative function
- determination of the range of doses
- experimental part
- preparing of report
Study of embryo-and phototoxic action in the antenatal period
- determination of the range of doses
- experimental part
- preparing of report
Allegicating action
Immunotoxic action
Pharmacological safety
- The cardiovascular system
- Respiratory system
- Nervous system
Specific pharmacological activity
- Cardiology - arterial hypertension; cerebral ischemia; arrhythmia
- Oncology - B-16 melanoma; Carcinoma LLC; Leukemia P-388
- Endocrinology - Diabetes; Osteoporosis; Hypophysectomy;
- Immunology and inflammation - Anaphylactic shock; Septic shock; Arthritis;
- Neurology - Autoimmune encephalomyelitis;
Pharmacokinetic studies 

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