Documents have been prepared for obtaining permis­sion from the Ministry of Health of Russia

CPD employees have prepared a number of protocols and related documents for obtaining permission from the Ministry of Health of the Russian Federation to conduct bioequivalence studies of medicines.

Studies

• of a nootropic drug used in the treatment of diseases of the central nervous system of various origins, especially diseases of vascular genesis or associated with disorders of metabolic processes in the brain and intoxication, accompanied by deterioration of intellectual and mental functions, decreased motor activity;
• antiviral drug active against HIV, used in the treatment of HIV infection caused by HIV-1 (as part of combined antiretroviral therapy), in adults and children; prevention of transplacental HIV infection of the fetus;
• antiviral drug (nucleotide reverse transcriptase inhibitor) used in the treatment of HIV-1 infection as part of combined antiretroviral therapy in adults;
• a drug (synthetic progestogen with a contraceptive effect) used as a means for emergency contraception due to pronounced gestagenic and antiestrogenic effects;
• a drug with immunomodulatory, hypocholesterolemic, hepatoprotective, choleretic and cholelitolytic pharmacological action used in the treatment of hepatitis (chronic, including atypical forms of chronic autoimmune, acute viral), non-alcoholic steatohepatitis, toxic (including alcoholic, medicinal) liver lesions, primary biliary cirrhosis and cystic fibrosis of the liver;
• adaptogenic, immunomodulating drug (stimulates the production of α- and γ-interferons, promotes the improvement and correction of the immune status of the body due to the activation of cellular and humoral immunity, stimulates the phagocytic activity of macrophages, strengthens the immune system of the body);
• a drug that eliminates magnesium deficiency, isolated or associated with other deficient conditions, accompanied by symptoms such as increased irritability, minor sleep disorders, gastrointestinal spasms, palpitations, increased fatigue, pain and muscle spasms, tingling sensation.