| Course Unit Title | Course Unit Code | Type of Course Unit | Level of Course Unit | Year of Study | Semester | ECTS Credits |
|---|---|---|---|---|---|---|
| Clinical Pharmacology | FRM710 | Elective | Doctorate degree | 2 | Fall | 3 |
Name of Lecturer(s)
Prof. Dr. Bekir Faruk ERDEN
Learning Outcomes of the Course Unit
1) Define the function of clinical pharmacology
2) Explains the ways of finding new drugs.
3) Describe preclinical drug development and clinical trial phases.
4) Describe the ethical aspects of clinical trial
5) Define pharmacovigilance and pharmaco-economy.
Program Competencies-Learning Outcomes Relation
| Program Competencies | |||||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | ||
| Learning Outcomes | |||||||||||||
| 1 | No relation | No relation | No relation | No relation | High | High | No relation | High | High | High | High | High | |
| 2 | No relation | No relation | No relation | No relation | Middle | Middle | No relation | Middle | Middle | Middle | Middle | Middle | |
| 3 | No relation | No relation | No relation | No relation | Middle | Middle | No relation | Middle | Middle | Middle | Middle | Middle | |
| 4 | No relation | No relation | No relation | No relation | High | High | No relation | High | High | High | High | High | |
| 5 | No relation | No relation | No relation | No relation | Middle | Middle | No relation | Middle | Middle | Middle | Middle | Middle | |
Mode of Delivery
Face to Face
Prerequisites and Co-Requisites
None
Recommended Optional Programme Components
GCP
Course Contents
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
Weekly Schedule
1) Etik kurullar2) Etik kurullar
3) Etik kurullar
4) Etik kurullar
5) Etik kurullar
6) Etik kurullar
7) Etik kurullar
8) Midterm examination/Assessment
9) insan üzerindeki ilaç araştırmaları
10) insan üzerindeki ilaç araştırmaları
11) Faz 1,2,3,4 ayrımı
12) Faz 1,2,3,4 ayrımı
13) farmakovijilans
14) farmakovijilans
15) farmakoekonomi
16) Final examination
Recommended or Required Reading
1- Kayaalp SO
Planned Learning Activities and Teaching Methods
1) Lecture
2) Question-Answer
3) Discussion
4) Group Study
5) Lab / Workshop
Assessment Methods and Criteria
Contribution of Midterm Examination to Course Grade |
40% |
|---|---|
Contribution of Final Examination to Course Grade |
60% |
Total |
100% |
Language of Instruction
Turkish
Work Placement(s)
Not Required