EFR508

2 ECTS - 2-0 Duration (T+A)- . Semester- 2 National Credit
Information About Course

Information
Goal, Content & Resources
Course Learning Outcomes
Relation with Program Learning Outcome
Week Plan
Student Workload - ECTS

Information

Code EFR508
Name
Semester . Semester
Duration (T+A) 2-0 (T-A) (17 Week)
ECTS 2 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

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

pubmed


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 and interprets clinical drug researches and phase studies.
LO04 Describe the national and international regulations in drug research.
LO05 Bioequivalence explains the points to be considered in biosimilarity drug research.
LO06 Defines the good clinical research practices.
LO07 Interprets the concepts of pharmacoeconomics and pharmacovigilance.
LO08 Explains and evaluates the working principles of ethics committees.
LO09 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. 3
PLO03 Beceriler - Bilişsel, Uygulamalı Can project and conduct research in the field of pharmacology and analyze and interpret data. 4
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. 3
PLO06 Bilgi - Kuramsal, Olgusal Follows scientific literature and current developments in the field of pharmacology. 4
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. 1
PLO09 Beceriler - Bilişsel, Uygulamalı Knows and uses good laboratory practices. 3
PLO10 Beceriler - Bilişsel, Uygulamalı Uses the theoretical and applied knowledge gained in the field of pharmacology. 2
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 2 ECTS