Educational process at the Chair of Standardization of Medicines

List of disciplines taught:

    Pharmaceutical Biotechnology (4th year of the Pharmaceutical Faculty of intramural and extramural education);
    Standardization of medicines (5th year of the Pharmaceutical Faculty and 6th year of extramural education);
    Industrial practice on quality control of medicines (5 courses of the pharmaceutical faculty of intramural and 6th year of extramural education).

Organization of educational process

The purpose of the discipline "Pharmaceutical Biotechnology" is to obtain and expand knowledge in the field of the molecular foundations of biotechnology, the general characteristics of the biotechnological process of obtaining medicines, the main stages of industrial production, methods for isolating and purifying the products of biotechnological productions. As a result of the course of pharmaceutical biotechnology, students acquire skills in orienting in the nomenclature of medicines obtained by biotechnological methods, substantiating the conditions for obtaining medicines and methods of quality control of medicines of biotechnological origin, technological and instrumental design of biotechnological productions.

Standardization of medicines is not only the final stage of the study of pharmaceutical analysis under the guidance of university teachers, but also a discipline that integrally approaches the issues of quality assurance of the drug throughout its life cycle. The life cycle of a medicinal agent includes the development, preclinical research, clinical trial, industrial production, pharmaceutical manufacture, sale, storage, transportation, medical use and destruction of medicinal agent. At the same time, each stage is fixed in the normative documentation and is accompanied by a number of conditions, the observance of which is necessary to obtain high-quality and safe medicines.

In this discipline, students are introduced to both documentary support for the production of medicines in accordance with international standards (quality assurance) and quality control of drugs in the intermediate and final stages of production (quality control) in accordance with the requirements of GMP. In addition, students receive the skills to develop original, innovative and generic medicines, in particular the basics of GRP, GLP and GCP. They also get acquainted with the rules of storage, transportation and sale of medicines (according to GSP, GPP, NEPAD, NAP). They receive the basics in the field of state registration and certification of medicines, development and approval of pharmacopoeial articles. Discipline is a planned and purposeful activity of students in mastering a chosen specialty, deepening the consolidation of theoretical knowledge, professional and creative skills.

The purpose of the discipline "Standardization of medicines" is the formation of an integral system of knowledge, skills and skills in the organization of quality assurance of medicines throughout their life cycle.

Under the supervision of teachers and pharmacists, students gain skills in working with the highly efficient liquid chromatograph Agilent 1100, Agilent 1260 with a collector of fractions and a diode array detector, a spectrophotometer (Specord-250) and an infrared spectrometer (Midac-4100).

During the implementation of the program of production practice for quality control of medicinal products, students work in production pharmacies at the workplace of the pharmacist-analyst for 4 weeks. Supervision of practice is carried out by university teachers, direct supervision in the workplace is carried out by an analytical pharmacist.

In addition, the elective course "Preclinical trials of medicines" in the amount of 21 hours is conducted for students at the department. The program of the elective course provides for the study of the theoretical principles of the chromatographic process, the physico-chemical basis for separation, and the application of the theoretical concepts obtained for setting up the experiment and explaining the results of chromatographic analysis. Particular attention is paid to chromatographic materials (sorbents, stationary and mobile phases), connections of the structure of organic substances with chromatographic characteristics of the separated compounds, quantitative determination of substances.

For the pharmacists and laboratory doctors of toxic-chemical laboratories, the department has organized a cycle of advanced training consisting of the following courses:

    Aspects of the safety and efficacy of drugs in pharmaceutical development.
    Modern instrumental methods of drug analysis in control and analytical laboratories
    Quality assurance system in pharmacy organizations
    Gas chromatography and mass spectrometry in chemical-toxicological studies of bio-media and environmental objects
    Liquid chromatography in drug analysis