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Quality Assessment of Medical and Pharmaceutical Technology (Drug Quality, Treatment Quality)

Major: Pharmacy, Industrial Pharmacy
Code of Subject: 8.226.00.M.24
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Рrof. Lubenets Vira
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
• ability to solve complex problems in the field of pharmacy, fine organic synthesis, pharmaceutical biochemistry, to carry out research and innovation activities, which implies deep rethinking of existing and creation of new holistic knowledge, as well as practical implementation of the obtained results;
• the ability to choose and apply the methodology and tools of scientific research in conducting theoretical and empirical research in the field of pharmacy;
• be able to integrate and apply the acquired knowledges from different cross- curricular spheres in the process of solving theoretical and applied problems in a specific field of research;
• the ability to form practical skills in the physicochemical methods of used in the study of chemical materials.
• the ability to apply knowledge of specific methods of physico-chemical research to identify organic compounds of substances of different classes, including potential medicinal substances.
Required prior and related subjects:
Disciplines, required to be studied before the course:
Regulatory support for registration of new medicines, Modern methods of identification of organic compounds.
Disciplines, required to be studied during the course:
Clinical and pharmaceutical basics of drug production, Use of medicines in clinical treatment.
Summary of the subject:
Methodology for conducting a clinical trial of a drug according to its individual phases and to its principles of good clinical practice; the responsibilities of participants of clinical trials; studies about general methodology and principles for drug selection for effective and safe pharmacotherapy based on systematic review and meta-analysis; study of registration rules, risk factors for development, and clinical manifestations of adverse drug reactions and study of principles for evaluating the efficacy and safety of the use of different pharmacological groups for their use in the clinic based on randomized clinical trial data.
Recommended Books:
1. Астахова А. В., Лепахин В.К. Неблагоприятные побочные реакции и
контроль безопасности лекарств; Руководство по фармнадзору. – М,
“Когито-Центр”, 2004. – 200с.
2. Клинические испытания лекарств / Под. ред. В.И. Мальцева, Т.К.
Ефимцевой, Ю.Б. Белоусова, В.Н. Коваленко. – 2-е изд., перераб. И доп. –
К.: МОРИОН, 2006. – 456 с.
3. Настанова з клінічних досліджень. Лікарські засоби. Дослідження
біодоступності та біоеквівалентності (Настанова 42-7.1:2005). – К.:
Міністерство охорони здоров’я України, 2005.
4. Настанова з клінічних досліджень. Лікарські засоби. Належна клінічна
практика. (Настанова СТ-Н МОЗУ 42-7.0: 2008). – К.: Міністерство
охорони здоров’я України, 2009.
5. Современные проблемы биоэтики: учебное пособие / В. А. Мороз, В.В.
Прописнова и др. – Харьков :Изд-во НФаУ, 2009.– 96 с.
Assessment methods and criteria:
• Continuous assessment: written-oral exam and defense of reports of practical works - 30 points;
• Final control - 70 points (exam): written-oral form.

Quality Assessment of Medical and Pharmaceutical Technology (Drug Quality, Treatment Quality)

Major: Pharmacy, Industry Pharrnacy
Code of Subject: 8.226.00.M.24
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Рrof. Lubenets Vira
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
• ability to solve complex problems in the field of pharmacy, fine organic synthesis, pharmaceutical biochemistry, to carry out research and innovation activities, which implies deep rethinking of existing and creation of new holistic knowledge, as well as practical implementation of the obtained results;
• the ability to choose and apply the methodology and tools of scientific research in conducting theoretical and empirical research in the field of pharmacy;
• be able to integrate and apply the acquired knowledges from different cross- curricular spheres in the process of solving theoretical and applied problems in a specific field of research;
• the ability to form practical skills in the physicochemical methods of used in the study of chemical materials.
• the ability to apply knowledge of specific methods of physico-chemical research to identify organic compounds of substances of different classes, including potential medicinal substances.
Required prior and related subjects:
Disciplines, required to be studied before the course:
Regulatory support for registration of new medicines, Modern methods of identification of organic compounds.
Disciplines, required to be studied during the course:
Clinical and pharmaceutical basics of drug production, Use of medicines in clinical treatment.
Summary of the subject:
Methodology for conducting a clinical trial of a drug according to its individual phases and to its principles of good clinical practice; the responsibilities of participants of clinical trials; studies about general methodology and principles for drug selection for effective and safe pharmacotherapy based on systematic review and meta-analysis; study of registration rules, risk factors for development, and clinical manifestations of adverse drug reactions and study of principles for evaluating the efficacy and safety of the use of different pharmacological groups for their use in the clinic based on randomized clinical trial data.
Recommended Books:
1. Астахова А. В., Лепахин В.К. Неблагоприятные побочные реакции и
контроль безопасности лекарств; Руководство по фармнадзору. – М,
“Когито-Центр”, 2004. – 200с.
2. Клинические испытания лекарств / Под. ред. В.И. Мальцева, Т.К.
Ефимцевой, Ю.Б. Белоусова, В.Н. Коваленко. – 2-е изд., перераб. И доп. –
К.: МОРИОН, 2006. – 456 с.
3. Настанова з клінічних досліджень. Лікарські засоби. Дослідження
біодоступності та біоеквівалентності (Настанова 42-7.1:2005). – К.:
Міністерство охорони здоров’я України, 2005.
4. Настанова з клінічних досліджень. Лікарські засоби. Належна клінічна
практика. (Настанова СТ-Н МОЗУ 42-7.0: 2008). – К.: Міністерство
охорони здоров’я України, 2009.
5. Современные проблемы биоэтики: учебное пособие / В. А. Мороз, В.В.
Прописнова и др. – Харьков :Изд-во НФаУ, 2009.– 96 с.
Assessment methods and criteria:
• Continuous assessment: written-oral exam and defense of reports of practical works - 30 points;
• Final control - 70 points (exam): written-oral form.