The aim of this course is to demonstrate the basic concepts and scope of clinical pharmacology.
Course Content
This course contains; Introduction, basic concepts,Drug discovery and development methods, phase studies,Ethical aspects of drug research,National and international legislation on drug research,Scientific research design in human subjects,Good clinical practice - GCP,MIDTERM EXAM,Clinical trials in special populations,Pharmacogenetics,Bioavailability and bioequivalence studies,Pharmacoeconomics,Pharmacovigilance,"Pseudo-medicine" practices,Ethics committee review,FINAL EXAM.
Dersin Öğrenme Kazanımları
Teaching Methods
Assessment Methods
Explain basic information about clinical pharmacology.
10, 13, 5, 9
A, D, E, F, H
Explain the licensing process of drugs.
10, 13, 5, 9
A, D, E, F, H
Analyze the ethics committee applications of clinical trials.
10, 13, 5, 9
A, D, E, F, H
Demonstrate the ability to develop attitudes about national drug policies
10, 13, 5, 9
A, D, E, F, H
Criticize and evaluate clinical research.
10, 13, 5, 9
A, D, E, F, H
Teaching Methods:
10: Discussion Method, 13: Case Study Method, 5: Cooperative Learning, 9: Lecture Method
Assessment Methods:
A: Traditional Written Exam, D: Oral Exam, E: Homework, F: Project Task, H: Performance Task
Course Outline
Order
Subjects
Preliminary Work
1
Introduction, basic concepts
Preparation for the previously given lecture note.
2
Drug discovery and development methods, phase studies
Preparation for the previously given lecture note.
3
Ethical aspects of drug research
Preparation for the previously given lecture note.
4
National and international legislation on drug research
Preparation for the previously given lecture note.
5
Scientific research design in human subjects
Preparation for the previously given lecture note.
6
Good clinical practice - GCP
Preparation for the previously given lecture note.
7
MIDTERM EXAM
Preparation for the previously given lecture note.
8
Clinical trials in special populations
Preparation for the previously given lecture note.
9
Pharmacogenetics
Preparation for the previously given lecture note.
10
Bioavailability and bioequivalence studies
Preparation for the previously given lecture note.
11
Pharmacoeconomics
Preparation for the previously given lecture note.
12
Pharmacovigilance
Preparation for the previously given lecture note.
13
"Pseudo-medicine" practices
Preparation for the previously given lecture note.
14
Ethics committee review
Preparation for the previously given lecture note.
15
FINAL EXAM
Preparation for the previously given lecture note.
Resources
Instructor's notes.
Goodman & Gilman’nın Tedavinin Farmakolojik Temeli - / Laurence L.Brunton - John S.Lazo - Keith L.Parker Nobel Tıp Kitapevleri Yayınları, İstanbul, 2008. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler, Oğuz Kayaalp, İlker Kanzık, Mehmet Melli, Şule Oktay, Hanefi Özbek, Demet Aydınkarahaliloğlu, Pelikan Yayınları, 2013. Katzung & Trevor's Pharmacology Examination and Board Review: Eighth Edition McGraw-Hill Medical Publishing USA, 2008. Rasyonel tedavi yönünden Tıbbi Farmakoloji 12. Baskı - Prof.Dr. Oğuz Kayaalp, Pelikan Yayınları, 2009.
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications
No
Program Qualification
Contribution Level
1
2
3
4
5
1
Has up-to-date knowledge, develops and deepens the level of expertise in the field of pharmacology based on the qualifications of the undergraduate level.
X
2
Knowledge of information technology, technical equipment and equipment and devices specific to the field at the level required by the field of pharmacology.
X
3
Has knowledge about statistics and uses related software effectively.
X
4
Analyzes and synthesizes the information that is available in the field of pharmacology using information from different disciplines and interprets them in order to create new information.
X
5
Writes the report of the research that you have done.
X
6
Performs necessary examinations and solves problems and problems by using advanced technological tools and equipment and tools specific to the field at the level required by the field of pharmacology.
X
7
Effective use of statistical software in pharmacology, accurate selection of statistical methods, accurate calculations and accurate interpretations.
X
8
Brings solution proposals, solves problems, evaluates the results obtained, and, where necessary, requires expertise in the pharmacology field.
X
9
Present a scientific article at a scientific meeting.
X
10
Evaluates critical knowledge about the field of pharmacology and guides learning. It follows applications based on proof. Conduct research that will create evidence in their field of professional practice.
X
11
Discuss and share the knowledge of the field of health, current developments and their own work in a systematic manner in written, oral and visual manner with the same group or outside groups.
X
12
Observes social, scientific and ethical values during the collection, registration, interpretation and announcement of data related to the health field.
X
13
Practice in interdisciplinary studies of knowledge and problem solving skills that are assimilated in the field of health.
X
Assessment Methods
Contribution Level
Absolute Evaluation
Rate of Midterm Exam to Success
50
Rate of Final Exam to Success
50
Total
100
ECTS / Workload Table
Activities
Number of
Duration(Hour)
Total Workload(Hour)
Course Hours
14
2
28
Guided Problem Solving
7
3
21
Resolution of Homework Problems and Submission as a Report
9
3
27
Term Project
2
5
10
Presentation of Project / Seminar
10
3
30
Quiz
14
1
14
Midterm Exam
10
5
50
General Exam
10
6
60
Performance Task, Maintenance Plan
0
0
0
Total Workload(Hour)
240
Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(240/30)
8
ECTS of the course: 30 hours of work is counted as 1 ECTS credit.
The aim of this course is to demonstrate the basic concepts and scope of clinical pharmacology.
Course Content
This course contains; Introduction, basic concepts,Drug discovery and development methods, phase studies,Ethical aspects of drug research,National and international legislation on drug research,Scientific research design in human subjects,Good clinical practice - GCP,MIDTERM EXAM,Clinical trials in special populations,Pharmacogenetics,Bioavailability and bioequivalence studies,Pharmacoeconomics,Pharmacovigilance,"Pseudo-medicine" practices,Ethics committee review,FINAL EXAM.
Dersin Öğrenme Kazanımları
Teaching Methods
Assessment Methods
Explain basic information about clinical pharmacology.
10, 13, 5, 9
A, D, E, F, H
Explain the licensing process of drugs.
10, 13, 5, 9
A, D, E, F, H
Analyze the ethics committee applications of clinical trials.
10, 13, 5, 9
A, D, E, F, H
Demonstrate the ability to develop attitudes about national drug policies
10, 13, 5, 9
A, D, E, F, H
Criticize and evaluate clinical research.
10, 13, 5, 9
A, D, E, F, H
Teaching Methods:
10: Discussion Method, 13: Case Study Method, 5: Cooperative Learning, 9: Lecture Method
Assessment Methods:
A: Traditional Written Exam, D: Oral Exam, E: Homework, F: Project Task, H: Performance Task
Course Outline
Order
Subjects
Preliminary Work
1
Introduction, basic concepts
Preparation for the previously given lecture note.
2
Drug discovery and development methods, phase studies
Preparation for the previously given lecture note.
3
Ethical aspects of drug research
Preparation for the previously given lecture note.
4
National and international legislation on drug research
Preparation for the previously given lecture note.
5
Scientific research design in human subjects
Preparation for the previously given lecture note.
6
Good clinical practice - GCP
Preparation for the previously given lecture note.
7
MIDTERM EXAM
Preparation for the previously given lecture note.
8
Clinical trials in special populations
Preparation for the previously given lecture note.
9
Pharmacogenetics
Preparation for the previously given lecture note.
10
Bioavailability and bioequivalence studies
Preparation for the previously given lecture note.
11
Pharmacoeconomics
Preparation for the previously given lecture note.
12
Pharmacovigilance
Preparation for the previously given lecture note.
13
"Pseudo-medicine" practices
Preparation for the previously given lecture note.
14
Ethics committee review
Preparation for the previously given lecture note.
15
FINAL EXAM
Preparation for the previously given lecture note.
Resources
Instructor's notes.
Goodman & Gilman’nın Tedavinin Farmakolojik Temeli - / Laurence L.Brunton - John S.Lazo - Keith L.Parker Nobel Tıp Kitapevleri Yayınları, İstanbul, 2008. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler, Oğuz Kayaalp, İlker Kanzık, Mehmet Melli, Şule Oktay, Hanefi Özbek, Demet Aydınkarahaliloğlu, Pelikan Yayınları, 2013. Katzung & Trevor's Pharmacology Examination and Board Review: Eighth Edition McGraw-Hill Medical Publishing USA, 2008. Rasyonel tedavi yönünden Tıbbi Farmakoloji 12. Baskı - Prof.Dr. Oğuz Kayaalp, Pelikan Yayınları, 2009.
Course Contribution to Program Qualifications
Course Contribution to Program Qualifications
No
Program Qualification
Contribution Level
1
2
3
4
5
1
Has up-to-date knowledge, develops and deepens the level of expertise in the field of pharmacology based on the qualifications of the undergraduate level.
X
2
Knowledge of information technology, technical equipment and equipment and devices specific to the field at the level required by the field of pharmacology.
X
3
Has knowledge about statistics and uses related software effectively.
X
4
Analyzes and synthesizes the information that is available in the field of pharmacology using information from different disciplines and interprets them in order to create new information.
X
5
Writes the report of the research that you have done.
X
6
Performs necessary examinations and solves problems and problems by using advanced technological tools and equipment and tools specific to the field at the level required by the field of pharmacology.
X
7
Effective use of statistical software in pharmacology, accurate selection of statistical methods, accurate calculations and accurate interpretations.
X
8
Brings solution proposals, solves problems, evaluates the results obtained, and, where necessary, requires expertise in the pharmacology field.
X
9
Present a scientific article at a scientific meeting.
X
10
Evaluates critical knowledge about the field of pharmacology and guides learning. It follows applications based on proof. Conduct research that will create evidence in their field of professional practice.
X
11
Discuss and share the knowledge of the field of health, current developments and their own work in a systematic manner in written, oral and visual manner with the same group or outside groups.
X
12
Observes social, scientific and ethical values during the collection, registration, interpretation and announcement of data related to the health field.
X
13
Practice in interdisciplinary studies of knowledge and problem solving skills that are assimilated in the field of health.
