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Preclinical analysis of biotechnology products

Обов’язкова дисципліна для ОП

Second

2021/2022

1 Semester

4

PR03. Carry out technical and economic calculations of design decisions and analyze and evaluate their effectiveness, environmental and social consequences in the short and long term. PR09. Be able to develop, justify and apply methods and means of protecting humans and the environment from hazardous factors of man-made and biological origin. PR14. Carry out the content of optimization problems in the field of biotechnology and bioengineering, their formalization, choose appropriate methods for solving such problems and obtain their solutions with a given degree of accuracy.

Full-time form

1. Successful mastering of PR courses "Bachelor". 2. Be able to independently perform laboratory and practical work, work with scientific and methodological literature. 3. Have basic skills in institutions conducting preclinical studies on the safety and efficacy of biopharmaceuticals.

The discipline "Preclinical analysis of biotechnology products" covers the study of basic principles of preclinical safety assessment of new drugs of biotechnological origin. The main types of preclinical studies and the rules of their conduct in accordance with the principles of Good Laboratory Practice (GLP) are studied; differences in approaches to assessing the safety of small molecules and biopharmaceuticals, which are related to both the production processes and the structure of the molecules themselves. Practical skills for test planning are formed; drawing up and using standard operating procedures (SOPs) and research protocols; correct registration of primary data; preparation of test reports; handling test systems.

1. Preclinical studies of drugs (guidelines) / Ed. O.V. Stefanova. - K .: Publishing house "Avicena", 2001. - S. 7-72. 2. Gad S. C. Drug safety evaluation. – John Wiley & Sons, 2016. 3. Guideline I. C. H. H. T. Preclinical sefety evaluation biotechnology-derived pharmaceuticals S6 // International Conference on Harmonisation. – 1997. 4. Tanina S.S., Shayakhmetova G.M., Karatsuba T.A., Khavich O.A., Tishkin S.M. Algorithmization of the implementation of GLP principles in clinical laboratory research / Modern achievements and prospects of clinical laboratory medicine in the diagnosis of human and animal diseases: materials of scientific and practical. international remote conf. (March 17, 2021) –X. : NUPh, 2021. - 122p.

Lecture, practical classes, independent work

Semester assessment: 1. Modular control work 1 - PH 1.1; 1.2. - 40 points / 20 points 2. Modular control work 2 - PH 1.3; 1.4 - 40 points / 20 points 3. Reports on practical work - PH 2.1; 3.1 - 10 points / 5 points 4. Test work - PH 2.1; 3.1; 4.1 - 10 points / 5 points Final assessment: in the form of a test

Ukrainian