ISTINYE UNIVERSITY BİLGİ PAKETİ / DERS KATALOĞU
| Pharmacy (English) | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
Course Introduction and Application Information
| Course Code: | PHA016 | ||||
| Course Name: | Clinical Studies | ||||
| Semester: | Spring | ||||
| Course Credits: |
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| Language of instruction: | English | ||||
| Course Condition: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Departmental Elective | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator: | Prof. Dr. SEMRA ŞARDAŞ | ||||
| Course Lecturer(s): | Dr. Öğr. Üyesi Aslıgül Kendirci | ||||
| Course Assistants: |
Course Objective and Content
| Course Objectives: | To share advanced knowledge on the basics of Clinical Research and to increase the knowledge and awareness of students who wish to work in this field. |
| Course Content: | Clinical Drug Trials |
Learning Outcomes
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The students who have succeeded in this course;
1) The student learns what clinical research is and why it is done. 2) The student learns the regulations, laws and rules in clinical research. 3) The student learns the parties and their responsibilities in clinical research. 4) The student knows clinical research methodologies. 5) The student knows the publication of the results of the study and the ethics of publication. |
Course Flow Plan
| Week | Subject | Related Preparation |
| 1) | What is research? Why is it done? Introduction to Clinical Studies | |
| 2) | Introduction to Research Ethics, History of Research Ethics | |
| 3) | What is the Declaration of Helsinki and why is it needed? | |
| 4) | Understanding the Good Clinical Practice Guidelines | |
| 5) | Development Process of the Drug, Overview of Pre-clinical Studies | |
| 6) | First use in patients, Clinical Drug Studies and Phases | |
| 7) | Midterm | |
| 8) | Bioavailability and Bioequivalence Studies | |
| 9) | Design and Methodology in Clinical Studies | |
| 10) | Selection of Research Center in Clinical Trials and Finding and Retention of Volunteers | |
| 11) | Counterparties and their responsibilities in Clinical Trials | |
| 12) | Application process for Approval in Clinical Trials | |
| 13) | Quality Assurance in Clinical Studies | |
| 14) | Publishing Ethics and Publishing | |
| 15) | Final |
Sources
| Course Notes / Textbooks: | Klinik Araştırmalar Kitabı- Editor: Prof.Dr. Hamdi Akan, Genişletilmiş Güncellenmiş Baskı 2010 Bilimsel Tıp Kitabevi Kayaalp SO. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler, Genişletilmiş 2. Baskı Ankara: Hacettepe Taş Kitapçılık, 2001 |
| References: | İYİ Klinik Uygulamalar Klavuzu, Nisan 2013 İlaç ve Biyolojik Ürünlerin Klinik Araştırmaları Hakkında Yönetmelik, 13.04.2013 ICH International Conference on Harmonisation of Technical Requirements for registration pharmaceuticals for human use) –GCP Guidelines, April, 2013 Dünya Tıp Birliği Helsinki Bildirgesi, Eylül 2015 GOOD Clinical Practices Guide, April 2013 Regulation on Clinical Trials of Pharmaceuticals and Biological Products, 13.04.2013 ICH International Conference on Harmonization of Technical Requirements for registration pharmaceuticals for human use) –GCP Guidelines, April, 2013 World Medical Association Declaration of Helsinki, September 2015 |
Course - Program Learning Outcome Relationship
| Course Learning Outcomes | 1 |
2 |
3 |
4 |
5 |
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|---|---|---|---|---|---|---|---|---|---|---|---|
| Program Outcomes | |||||||||||
| 1) Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 3 | 3 | 3 | 3 | 3 | ||||||
| 2) Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 3 | 3 | 3 | 3 | 3 | ||||||
| 3) Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |||||||||||
| 4) Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | |||||||||||
| 5) Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |||||||||||
| 6) Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |||||||||||
| 7) Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |||||||||||
| 8) He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | |||||||||||
| 9) Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | |||||||||||
| 10) As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 | 3 | 3 | 3 | 3 | ||||||
| 11) He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 | 3 | 3 | 3 | 3 | ||||||
Course - Learning Outcome Relationship
| No Effect | 1 Lowest | 2 Average | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 3 |
| 2) | Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 3 |
| 3) | Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |
| 4) | Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | |
| 5) | Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |
| 6) | Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |
| 7) | Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |
| 8) | He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | |
| 9) | Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | |
| 10) | As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 |
| 11) | He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 |
Assessment & Grading
| Semester Requirements | Number of Activities | Level of Contribution |
| Midterms | 1 | % 30 |
| Final | 1 | % 70 |
| total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 30 | |
| PERCENTAGE OF FINAL WORK | % 70 | |
| total | % 100 | |
Workload and ECTS Credit Calculation
| Activities | Number of Activities | Workload |
| Course Hours | 14 | 28 |
| Study Hours Out of Class | 14 | 53 |
| Midterms | 1 | 2 |
| Final | 1 | 2 |
| Total Workload | 85 | |