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Fundamentals of pharmacopoeia

Вибіркова дисципліна для ОП

First

2023/2024

8 Semester

4

PR4. Be able to identify and analyze the basic properties of biological agents and their components and organic compounds that make up their composition (proteins, nucleic acids, carbohydrates, lipids). PR10. To be able to conduct experimental studies to determine the impact of physicochemical and biological environmental factors on the vital activity of cells of living organisms. PR13. Analyze and apply the provisions of regulatory and technical documents governing the procedure for product certification, production certification, requirements for the organization of quality management systems at enterprises, rules for the preparation of technical documentation and conducting the technological process. PR 1, 5.

Full-time form

1. Successful mastering of scientific-theoretical and practical material academic disciplines taught to students of educational level "Bachelor", in particular "Biochemistry", "Biophysics", "Human Physiology and Animals "," Molecular Biology "," General and Molecular Genetics ", "Virology", "Microbiology". 2. Be able to independently apply knowledge of biochemistry, molecular biology, biophysics, etc. disciplines, perform laboratory work, work with scientific and methodological literature. 3. Have computer skills, materials and equipment used in biological and specialized analytical laboratories.

The discipline "Fundamentals of Pharmacopoeia" is devoted to the study theoretical and practical aspects of a wide range of relevant issues general requirements for drugs, technological regulations for the manufacture of those or other medicines, methods of quality control (including purity), packaging, conditions and shelf life, etc. Considerable attention is paid to close relationships between pharmacology, pharmaceuticals and biotechnology industries and, in particular, the formation of the modern branch of pharmaceutical biotechnology, in which the principles of biotechnology are used in the process of creating new ones drugs. It is noted that a large number of therapeutic drugs on the market today are biologicals such as antibodies, nucleic acid products and vaccines, the main stages are considered processes of development, certification and production of medicines.

1. State Pharmacopoeia of Ukraine, 2nd edition (SPU 2.0) in 3 volumes / State enterprise "Ukrainian Scientific Pharmacopoeial Center of Quality medicines ". - Kharkiv, 2014. 2. Sharapova TA, Berest GG, Bigdan OA Quality, standardization and certification of medicines. Tutorial. - Zaporozhye, 2016. - 96 p. 3. Information resources of the State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Drug Quality ”. [Electronic resource] Access mode: http://sphu.org/korisni-posilannya. 4. Baula OP, Derkach TM. Quality assurance of herbal medicines origin: status and prospects. Pharmaceutical Review, 2017, №2, pp. 79-86. [Electronic resource] Access mode: https://ojs.tdmu.edu.ua/index.php/pharmchas/article/view/7816/7252.

Lecture, laboratory work, independent work

Semester assessment: 1. Modular control work 1 - PH 1.1; 1.2 (Block of topics of section I) - 15 points / 7.5 points 2. Modular control work 2 - PH 1.3; 1.4 (Block of topics of section II) - 15 points / 7.5 points 3. Presentation on a given topic (evaluation of oral reports) - RN 3.1 - 10 points / 5 points 3. Evaluation of reports on laboratory work - RN 2.1; 2.2; 3.1 - 10 points / 5 points 4. Intermediate testing of pH 1.1-1.4 - 10 points / 5 points Final assessment: in the form of an exam

Ukrainian