TÜRKÇE
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Information
| Code | EFR508 |
| Name | |
| Term | 2022-2023 Academic Year |
| Semester | . Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 4 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Yüksek Lisans Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator |
Course Goal / Objective
At the end of the course, it is aimed that the students define the basic concepts about the drug research and development process, explain the drug development process, phase studies, drug studies in special patient groups and the working principles of ethical committees.
Course Content
Drug development process, drug research, clinical phase studies, drug research in special patient groups, ethical committees and their processes
Course Precondition
None
Resources
Goodman and Gilman's The Pharmacologi-cal Basis of Therapeutics-13 th Edition, McGraw-Hill Medical Books, 2018
Notes
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Defines the basic concepts related to drug research |
| LO02 | Explain the design of preclinical studies, use of experimental animals and ethical rules. |
| LO03 | Explain the design of preclinical studies, use of experimental animals and ethical rules. |
| LO04 | Explain and interprets clinical drug researches and phase studies. |
| LO05 | Describe the national and international regulations in drug research. |
| LO06 | Bioequivalence explains the points to be considered in biosimilarity drug research. |
| LO07 | Defines the good clinical research practices. |
| LO08 | Interprets the concepts of pharmacoeconomics and pharmacovigilance. |
| LO09 | Explains and evaluates the working principles of ethics committees. |
| LO10 | Explains drug researches in special research groups. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Explain the mechanisms of action of drugs, their pharmacokinetic and pharmacodynamic effects. | |
| PLO02 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Acts in accordance with ethical and legal principles in the field of pharmacology. | |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Can project and conduct research in the field of pharmacology and analyze and interpret data. | |
| PLO04 | Yetkinlikler - Alana Özgü Yetkinlik | It plays an active role in rational drug use and provides counseling to the patient for the correct use of the drug. | |
| PLO05 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Can convey the current developments or studies in the field of pharmacology verbally or in writing. | |
| PLO06 | Bilgi - Kuramsal, Olgusal | Follows scientific literature and current developments in the field of pharmacology. | |
| PLO07 | Bilgi - Kuramsal, Olgusal | Establishes a relationship between the effects, mechanisms of action and drug interactions of drugs. | |
| PLO08 | Bilgi - Kuramsal, Olgusal | Explain the physiopathology of various diseases and evalue the drugs used in the treatment of these diseases. | |
| PLO09 | Beceriler - Bilişsel, Uygulamalı | Knows and uses good laboratory practices. | |
| PLO10 | Beceriler - Bilişsel, Uygulamalı | Uses the theoretical and applied knowledge gained in the field of pharmacology. | |
| PLO11 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Have the ability to take part in in vitro/in vivo animal studies. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Introduction | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım |
| 2 | Discovery and Historical Development of Medicine | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 3 | General Concepts in Preclinical Drug Research | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 4 | Use of Laboratory Animals, Experimental Design and Ethical Rules | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 5 | Clinical Drug Studies, Phase Studies | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 6 | Ethical Aspects of Pharmaceutical Research | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Tartışma |
| 7 | National and International Legislation in Pharmaceutical Research | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 8 | Mid-Term Exam | Preparing the presentation | Ölçme Yöntemleri: Ödev |
| 9 | Good Clinical Practices (GCP) | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 10 | Drug Researchs in Special Patient Groups | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 11 | Bioavailability And Bioequivalence Research Considerations And Rules | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Beyin Fırtınası, Anlatım |
| 12 | Pharmacovigilance and Pharmacoeconomy | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 13 | Licensing Stages of Drugs | The subject should be reviewed from the textbooks | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 14 | Ethics Committees and Their Operations | The subject should be search | Öğretim Yöntemleri: Tartışma, Beyin Fırtınası, Anlatım |
| 15 | Overview and Discussion | Notes should be reviewed | Öğretim Yöntemleri: Soru-Cevap, Tartışma |
| 16 | Term Exams | Presentations should be reviewed | Ölçme Yöntemleri: Yazılı Sınav |
| 17 | Term Exams | Presentations should be reviewed | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 4 | 4 |
| Final Exam | 1 | 8 | 8 |
| Total Workload (Hour) | 54 | ||
| Total Workload / 25 (h) | 2,16 | ||
| ECTS | 4 ECTS | ||