ERU602 - PRINCIPLES of SAFETY DRUG USAGE IN REGUL AFFAIRS
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| PRINCIPLES of SAFETY DRUG USAGE IN REGUL AFFAIRS | ERU602 | 2nd Semester | 2 | 2 | 3 | 6 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Must | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion | |||||
| Instructor (s) | Prof. Dr. TURGUT EMRAH BOZKURT, Prof. Dr. TERKEN BAYDAR,Dr. Ögr. Üyesi MERVE DENIZALTI,Dr. Ögr. Üyesi MELIKE HACER ÖZKAN,Prof. Dr. SUNA SABUNCUOGLU, Doç. Dr. GÖZDE GIRGIN,Prof. Dr. ÜLFET PINAR ERKEKOGLU,Prof. Dr. SEVTAP AYDIN DILSIZ,Prof. Dr. ÜLKÜ ÜNDEGER BUCURGAT,Prof. Dr. AYLIN GÜRBAY | |||||
| Course objective | The necessary basic principles in evaluating the safety drug usage data in registration files and the ability to access basic information in the regulatory affairs will be provided. | |||||
| Learning outcomes |
| |||||
| Course Content | This course is designed to give the students the background of safety drug use. Program titles are: - Regulations of drug investigations and ethics in clinical trials, -Bioavailability and bioequivalence, and the regulations. -Factors modifiying the therapeutic effects of drugs -Drug-drug interactions -Food, alcohol and herbal medicine-drug interactions -Safety drug usage in special groups (pediatry, geriatry, pregnancy) -Pharmacovigilance / Toxicovigilance -Evaluations of clinical data in registration files | |||||
| References | 1.Rasyonel tedavi yönünden Tıbbi Farmakoloji (Prof. Dr. Oğuz Kayaalp), Klinik Farmakolojinin Esasları (Prof. Dr. Oğuz Kayaalp), 2.Türkiye İlaç Kılavuzu 2005 formüleri, 3.Drug Information Handbook 2012 4.General and Applied Toxicology (Ballantyne B, Marrs T, Syversen T), 2000, 5.Cassarett&Dolls Toxicology, The Basic Science of Poisons (Klaassen CD), 2001. | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Clinical evaluation methods in drug research |
| Week 2 | Ethical aspects in clinical drug research |
| Week 3 | Bioavailability and bioequivalence, Regulations on bioavailability and bioequivalence of pharmaceutical preparations |
| Week 4 | Factors that change drug activity |
| Week 5 | Interactions between drugs (Pharmacodynamic and pharmacokinetic drug interactions: general principles) |
| Week 6 | Pharmaceutical-food and alcohol; Interactions between drugs and herbal products |
| Week 7 | Safe drug use at risky periods: pregnancy and lactation |
| Week 8 | Safe drug useat risky periods: Pediatrics and geriatrics |
| Week 9 | Safe drug use at risky periods: Liver and kidney diseases |
| Week 10 | Treatment approaches in drug poisoning |
| Week 11 | Pharmacovigilance |
| Week 12 | Evaluation of clinical data in drug registration files |
| Week 13 | Evaluation of clinical data in drug registration files |
| Week 14 | Discussion |
| Week 15 | Final Exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 0 | 0 |
| Final exam | 1 | 100 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 0 | 0 |
| Percentage of final exam contributing grade succes | 1 | 100 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 2 | 28 |
| Laboratory | 0 | 0 | 0 |
| Application | 14 | 2 | 28 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 6 | 84 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 0 | 0 | 0 |
| Final Exam (Study duration) | 1 | 40 | 40 |
| Total Workload | 43 | 50 | 180 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has basic theoretical concepts and related approaches to provide quality in control systems used in analytical data and method validations | |||||
| 2. Has capability to decide conformity tests and to evaluate results by arranging different conditions, planning the activities for method validation and quality control | |||||
| 3. Has able to evaluate statistical data used for licensing medicinal products | |||||
| 4. Has knowledge on the definition of drug, formulations, properties, production and quality controls | |||||
| 5. Has knowledge on pharmaceutical technology in evaluating and/or preparing application dossier of licensing medicines | |||||
| 6. Has pharmacological and toxicological knowledge for licensing medicinal products | X | ||||
| 7. Has satisfied knowledge on safely usage of medicines. | X | ||||
| 8. Has basic and technical knowledge about radiopharmaceutics; preparing, evaluating and resulting ability for applied license dossier of radiopharmaceuticals. | |||||
| 9. Capable to perform researches on different subjects; can follow published scientific studies; can plan and end a research; able to write a report with the data. | X | ||||
| 10. Has a general idea on pharmaceutical biotechnology. | |||||
| 11. Has basic and important pharmacological and toxicological knowledge on biological products. | X | ||||
| 12. Has a general knowledge in registration of natural medicines, medicine out products, cosmetics, and food supplements. | |||||
| 13. Capable to discuss and/or defend pharmacoeconomic data in medicine licensing. | |||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest