Vol 70, No 3 (2021)

The paper defines the place of real world evidence (RWE) in evidence-based medicine and its role in modern healthcare by the example of psoriasis on the basis of the works published in the MedLine, PubMed, and Cochrane Library databases in 2010-2020. It considers the advantages and disadvantages of RWE studies and randomized clinical trials (RCTs). It is noted that the data of both types of studies can complement each other. In the foreseeable future, RCTs will remain necessary for the initial approval of drugs and treatments that must be initially demonstrated to be effective in the primary target group and for the primary indication in the RCTs before they can be introduced into the RWE. RWE studies will be able to more effectively identify the unresolved medical needs and molecular targets for further elaboration of therapeutic approaches, to register drugs, and to expand their range of indications. As the drawbacks in the structure of RWE studies are corrected, the importance of this method will grow in the clinical, regulatory, and economic areas of healthcare.

Introduction. Amino acids, including essential ones, enter the human body in a ready-made form, i.e. with food. Therefore, the amino acid characteristics of plant products are an important indicator of their nutritional value. Indian sesame (Sesamumindicum) seeds contain a valuable complex of biologically active substances and are a source of fatty oil that can serve as an olive oil substitute. In addition to the fatty oil, the sesame seeds contain lignin, sesamin, phenolic compounds, etc. Objective: to study of the qualitative composition and quantitative content of amino acids in the Indian sesame seeds. Material and methods. The investigation object was Indian sesame seeds harvested in the Kashkadarya Region of the Republic of Uzbekistan in 2017-2018. Paper chromatography and HPLC techniques were used. Results. The Indian sesame seeds were found to contain 20 free amino acids, including eight essential ones. The amino acid complex of sesame seeds had high levels of glutamic acid, leucine, aspartic acid, and serine. The total content of amino acids in the aqueous extract from sesame seeds was 11.0099 mg/g. The quantitative content of essential amino acids was 31.76% of the amount of amino acids. Conclusion. The qualitative composition of the amino acid complex of Indian sesame seeds and the content of individual amino acids were determined

Introduction. The representatives of the Syringa genus are valuable medicinal plants that have immunomodulatory, adaptogenic, antidepressant, and anxiolytic activities. The bark of common lilac (Syringa vulgaris) is registered as a medicinal plant raw material. The promising type of raw material is common lilac flowers that contain phenylpropanoids. Objective: to develop a procedure for quantitative determination of the amount of phenylpropanoids in the common lilac flowers. Material and methods. Common lilac flowers were investigated by direct spectrophotometry using the standard sample of chlorogenic acid. Results. The investigators defined optimal conditions for the extraction of phenylpropanoids from common lilac flowers: the extraction solvent was 60% ethyl alcohol; the raw material-to-extraction solvent ratio was 1:100; the extraction time was 45 min; the grinding degree was 1 mm. The total content of phenylpropanoids calculated with reference to chlorogenic acid in the common lilac flowers was found to range from 5.54 to 6.19%. Conclusion. A procedure has been developed to quantify the amount of phenylpropanoids in the common lilac flowers by direct spectrophotometry using the standard sample of chlorogenic acid at an analytical wavelength of 330 nm. The error of a single measurement at a 95% confidence interval is ±1.89%.

Introduction. Drugs of natural origin, which are obtained from animal organs and tissues, are growing in popularity. In Russia, only an Arctic caribou (Rangifertarandus) meets ideal requirements to be a donor of the organs used to produce drugs that compensate for the human body with vital biologically active substances. The enzyme а-amylase is widely used in medicine. It is known that the high activity of а-amylase is observed in the pancreas of cattle. Objective: to determine the qualitative composition of amino acids in the parotid gland of an Arctic caribou and to select optimal conditions for the isolation and purification of а-amylase. Material and methods. The parotid gland of the Arctic caribou was investigated. The elemental composition was determined by gel chromatography and gel electrophoresis. The amino acid composition was determined by high-performance liquid chromatography (HPLC). Extraction and adsorption chromatographic methods were used to isolate and purify а-amylase. Results. An isotonic solution was chosen as an optimal extraction medium for а-amylase; KU-23 was an optimal sorbent for its purification. Conclusion. The amino acid composition was determined in the parotid gland of an Arctic caribou. Optimal conditions were selected for the isolation and purification of а-amylase from the Arctic caribou parotid gland.

Introduction. Preclinical trials (PCTs) as one of the stages of the drug life cycle are conducted in accordance with good laboratory practice (GLP). GLP is a quality system that deals with the organization of the process and the conditions under which it is planned to conduct, as well as to monitor, record, and archive the results of PCTs. GLP is designed to standardize and unify all PCTs, by using standard and validated methods and procedures. The carefully controlled conditions and processes allow one to obtain results that meet the criteria for reproducibility and tracking of data acquisition. The task of regulatory authorities is to monitor (inspect) research centers (RCs) for compliance with the requirements of the GLP regulations in order to ensure the proper performance of PCTs of drug candidates. Objective: to study of the principles of monitoring the assessment of the compliance of RCs with the GLP requirements, as well as the results of these assessments by regulatory authorities. Material and methods. The materials were foreign and Russian regulatory documents, accounting documents of the Federal Health Service of Russia and the US Food and Drug Administration. The study used information and analytical methods, retrospective and content analysis. Results. The methodological approaches to regulating the RCs conducting drug PCTs in the Russian Federation were studied. The report documents on making inspections in Russia and the United States were analyzed. The number and nature of violations were investigated according to the defined criteria. Conclusion. The analysis of the regulation of RCs in the Russian Federation has shown the compliance with the formal WHO indicators for assessing the activities of national regulators in drug circulation. It has been found that in Russia there are no accreditation requirements for conducting drug PCTs. There are general accreditation requirements for laboratory activities in any field, which are confirmed for each type of activity and include methods and test objects. A laboratory can conduct PCTs within the obtained accreditation framework. The results have indicated that much more inspections are made in the Russian Federation than in the United States.