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Clinical and Pharmaceutical Basis for the Creation of Medicines (Principles of Search of New Drugs, New Drug Investigation, Implementation in Clinical Practice)

Major: Pharmacy, Industrial Pharmacy
Code of Subject: 8.226.00.M.23
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph. D. Nataliya Zayarnyuk
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
• the ability to form approaches to pharmaceutical development of new drugs;
• knowledge requirements for physical-chemical, pharmaco-technological, biological, pre-clinical and clinical trials;
• understanding of the quality assurance of medical zasobivyu;
• ability to summarize the current understanding of the concept and structure of organic compounds, its relation to their reactivity, physicochemical and pharmacological properties.
Required prior and related subjects:
• Scientific aspects of veterinary technology and biomedpreparativ
• Industrial pharmaceutical technology industries, Part 1 and 2
• Scientific aspects of veterinary technology and biomedpreparativ
• Good practice in pharmacy
• The use of medicines in clinical practice
• Assessing the quality of medical and pharmaceutical technology
Summary of the subject:
The principles of the search for new drugs. Marketing research. The aim and purpose of pharmaceutical formulation. Components of drugs, active ingredients, connection structures of biologically active compounds, their physical and chemical properties and pharmacological properties. Compatibility of component drugs. The optimal dosage form. Excipients. Justification sheets as active substances and excipients with the inclusion of indicators of quality that may affect the efficacy and safety of the finished product. Research of new drugs. Choosing appropriate research methods, rules of conduct. Pharmacological studies, determination of specific activity and toxicity. Optimization of the process. Justification of the method of evaluating the effectiveness and safety of generic drugs. Conducting of clinical trials.
Recommended Books:
1. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2015. – Т.1 – 1128 с.
2. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2014. – Т.2 – 724 с.
3. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2014. – Т.3 – 732 с.
4. Державна Фармакопея України.–2 вид., 1 допов. – Х. : ДП «Укр. наук. ц-р як-і»,, 2016. –366 с.
5. Державна Фармакопея України.–2 вид., 2 допов. – Х. : ДП «Укр. наук. ц-р як-і», 2018. – 416 с.
6. Настанова СТ-Н МОЗУ42-3.0:2011. – Лікарські засоби. Фармацевтична розробка(ICH Q8) – Київ, МОЗ України, 2012. – VIII + 28 с.
7. EMA/INS/GMP/79766/2011. – QualityRisk Management (ICH Q9), 31 January 2011.
8. Настанова СТ-Н МОЗУ42-4.2:2011. – Лікарські засоби. Управління ризиками для якості(ICH Q9) – Київ, МОЗ України, 2012. – VIII + 22 с.
9. EMA/INS/GMP/79818/2011. – Pharmaceutical Quality System (ICH Q10), 31 January 2011.
10. Настанова СТ-Н МОЗУ42-4.3:2011. – Лікарські засоби. Фармацевтична система якості(ICH Q10)– Київ, МОЗ України, 2012. – VIII + 18 с.
Assessment methods and criteria:
• сurrent control, practical work - 40%
• control measure, exam - 60%.

Clinical and Pharmaceutical Basis for the Creation of Medicines (Principles of Search of New Drugs, New Drug Investigation, Implementation in Clinical Practice)

Major: Pharmacy, Industry Pharrnacy
Code of Subject: 8.226.00.M.23
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph. D. Nataliya Zayarnyuk
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
• the ability to form approaches to pharmaceutical development of new drugs;
• knowledge requirements for physical-chemical, pharmaco-technological, biological, pre-clinical and clinical trials;
• understanding of the quality assurance of medical zasobivyu;
• ability to summarize the current understanding of the concept and structure of organic compounds, its relation to their reactivity, physicochemical and pharmacological properties.
Required prior and related subjects:
• Scientific aspects of veterinary technology and biomedpreparativ
• Industrial pharmaceutical technology industries, Part 1 and 2
• Scientific aspects of veterinary technology and biomedpreparativ
• Good practice in pharmacy
• The use of medicines in clinical practice
• Assessing the quality of medical and pharmaceutical technology
Summary of the subject:
The principles of the search for new drugs. Marketing research. The aim and purpose of pharmaceutical formulation. Components of drugs, active ingredients, connection structures of biologically active compounds, their physical and chemical properties and pharmacological properties. Compatibility of component drugs. The optimal dosage form. Excipients. Justification sheets as active substances and excipients with the inclusion of indicators of quality that may affect the efficacy and safety of the finished product. Research of new drugs. Choosing appropriate research methods, rules of conduct. Pharmacological studies, determination of specific activity and toxicity. Optimization of the process. Justification of the method of evaluating the effectiveness and safety of generic drugs. Conducting of clinical trials.
Recommended Books:
1. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2015. – Т.1 – 1128 с.
2. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2014. – Т.2 – 724 с.
3. Державна Фармакопея України. –2 вид-я. – Х. : ДП «Укр. наук. ц-р як-і», 2014. – Т.3 – 732 с.
4. Державна Фармакопея України.–2 вид., 1 допов. – Х. : ДП «Укр. наук. ц-р як-і»,, 2016. –366 с.
5. Державна Фармакопея України.–2 вид., 2 допов. – Х. : ДП «Укр. наук. ц-р як-і», 2018. – 416 с.
6. Настанова СТ-Н МОЗУ42-3.0:2011. – Лікарські засоби. Фармацевтична розробка(ICH Q8) – Київ, МОЗ України, 2012. – VIII + 28 с.
7. EMA/INS/GMP/79766/2011. – QualityRisk Management (ICH Q9), 31 January 2011.
8. Настанова СТ-Н МОЗУ42-4.2:2011. – Лікарські засоби. Управління ризиками для якості(ICH Q9) – Київ, МОЗ України, 2012. – VIII + 22 с.
9. EMA/INS/GMP/79818/2011. – Pharmaceutical Quality System (ICH Q10), 31 January 2011.
10. Настанова СТ-Н МОЗУ42-4.3:2011. – Лікарські засоби. Фармацевтична система якості(ICH Q10)– Київ, МОЗ України, 2012. – VIII + 18 с.
Assessment methods and criteria:
• сurrent control, practical work - 40%
• control measure, exam - 60%.