Infopaket

Quality control of medicines

ВБ.6.02

Вибіркова дисципліна для ОП

Second

2022/2023

2 Semester

3

Apply the acquired knowledge and understanding to solve new qualitative and quantitative problems of chemistry. Know the methodology and organization of scientific research. Collect, evaluate and analyze data necessary for solving complex problems of chemistry, using appropriate methods and tools for working with data. Plan, organize and carry out experimental research in chemistry using modern equipment, competently process their results and draw reasonable conclusions. Draw up a technical task for the project, allocate time, organize your work and the work of the team, draw up a report. Assess risks in professional activity and take preventive actions.

Full-time form

1. To know the legislation of Ukraine, which regulates the quality control of medicinal products. 2. To know the basic principles of pharmaceutical analysis. 3. To have knowledge about the organization of quality control of medicinal products 4. To know the basic methods of sample preparation and determination in the analysis of medicinal products. products 5. Have knowledge of methods of quality control of medicinal forms.

The discipline is dedicated to getting to know and mastering the theoretical principles, laws and practical aspects of the analysis of the quality of medicinal products. The discipline should provide knowledge of the basic theoretical principles of pharmaceutical analysis, regulatory documentation, the procedure for implementation and methods of determining the quality of medicinal products.

1. Bezugliy P.O. Pharmaceutical chemistry: Education. manual / For. ed. P.O. Bezuglio - Kh.: Publication of NFAU; Golden pages, 2002. - 448 p. 2. Bezugliy P.O. Pharmaceutical chemistry: Education. manual / Under the editorship P.O. Bezuglio - Vinnytsia, NOVA KNYGA, 2006. -552 p. 3. Bezugliy P.O. Pharmaceutical analysis: Study. manual / Under the editorship P.O. Bezuglio.- Kh.: Publication of the National Academy of Sciences; Golden pages, 2001.— 240 p. 4. Modern requirements for the organization of the work of laboratories for the analysis of the quality of medicinal products / V.G. Varchenko, S.V. Sur, V.P. Chernykh and others. - X.: Publishing House of NFAU, 2002. - 202 p. 5. Pharmaceutical analysis. Methodical recommendations for a special course / Compiled by V.O. Doroshchuk, A.S. Shalamai, S.O. Fesenko, O.A., Doroshchuk, S.A. Kulichenko. - K. : Sciences. World, 2008. -96 p.

Lectures, seminars, individual work

Evaluation by forms of control Content module 1. Maximum score (k1): 20 points. The module includes 1 modular control paper, which is valued at 20 points. Content module 2.Maximum score (k2): 20 points. The module includes 1 modular control paper, which is valued at 20 points. Individual work. Maximum score (k3): 20 points.The grade for preparing an essay on the course topic, which is the sum of grades for content (8 points), design (5 points) and essay defense (7 points): k3 = 8 (content) + 7 (protection) + 5 (design) = 20 (points). Exam. Maximum score (k4): ​​40 points. k4 = 40 (points). According to the results of the semester, the student receives a final grade based on the 100-point system K = k1 + k2 + k3 + k4"

Ukrainian