Data
Official data in SubjectManager for the following academic year: 2024-2025
Course director
-
Börzsei Rita Judit
assistant professor,
-
Number of hours/semester
lectures: 15 hours
practices: 0 hours
seminars: 0 hours
total of: 15 hours
Subject data
- Code of subject: OPG-KLF-T
- 1 kredit
- Pharmacy
- Pharmaceutical theoretical module and practical skills modul
- autumn
OPG-D3E-T parallel , OPG-KL2-T parallel
Course headcount limitations
min. 5 – max. 40
Topic
In the frame of this one semester subject (15 lectures) students get acquainted with the next clinical pharmacological terms and sections: history of the drug research, rational drug design, preclinical development, safety pharmacology, clinical studies (Phase I-II-III-IV), Good Clinical Practice. Documentation of clinical trials. Practical aspects of clinical studies. Evidence-based medicine.
Lectures
- 1. History of drugs - Sánticsné Pintér Erika
- 2. History of drugs - Sánticsné Pintér Erika
- 3. The process of modern drug development - Hetényi Csaba
- 4. Drug discovery - Hetényi Csaba
- 5. Drug discovery - Hetényi Csaba
- 6. Drug discovery - Hetényi Csaba
- 7. Preclinical testing - Börzsei Rita Judit
- 8. Preclinical testing - Börzsei Rita Judit
- 9. Preclinical testing - Börzsei Rita Judit
- 10. Design and conduct of clinical trials - Sánticsné Pintér Erika
- 11. Design and conduct of clinical trials - Sánticsné Pintér Erika
- 12. Design and conduct of clinical trials - Sánticsné Pintér Erika
- 13. GMP, GLP, GCP - Börzsei Rita Judit
- 14. GMP, GLP, GCP - Börzsei Rita Judit
- 15. Documentation of the clinical studies - Börzsei Rita Judit
Practices
Seminars
Reading material
Obligatory literature
None
Literature developed by the Department
Lectures made available on Neptun.
Notes
None
Recommended literature
None
Conditions for acceptance of the semester
Maximum 15% absence is allowed.
Mid-term exams
None
Making up for missed classes
None
Exam topics/questions
Written exam based on the lectures
Examiners
- Börzsei Rita Judit
Instructor / tutor of practices and seminars
- Börzsei Rita Judit
- Hetényi Csaba
- Sánticsné Pintér Erika