ERU608 - PRODUCTS of PHARMA BIOTECH&PRINCIPLES IN LICENCING
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| PRODUCTS of PHARMA BIOTECH&PRINCIPLES IN LICENCING | ERU608 | 2nd Semester | 1 | 0 | 1 | 2 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion | |||||
| Instructor (s) | Prof.Dr. Betül Arıca Yeğin | |||||
| Course objective | It is aimed to give a general knowledge about Pharmaceutical Biotechnology products. | |||||
| Learning outcomes |
| |||||
| Course Content | Issues relating with the production and licencing of pharmaceutical biotechnology products prepared with recombinant peptides-proteins, vaccines, monoclonal antibodies and gene therapeutics. | |||||
| References | 1. Gary Walsh, Pharmaceutical Biotechnology,Concepts and Applications, John Wiley & Sons, England, 2007 2. Crommelin, D.J.A., Sindelar, R.D., Pharmaceutical Biotechnology, Harwood Academic Publishers, Amsterdam, 1997. 3. Zito, S.W., Pharmaceutical Biotechnology, Technomic Publishing CO., Inc., Lancaster, 1997. 4. Glick, B.R., Pasternak, J.J., Molecular Biotechnology, ASM Press, Washington, D.C., 2007 5. Groves M, J., Klegerman, M.E., Pharmaceutical Biotechnology Fundamentals and Essentials, Interpharm Press, Inc., Buffalo Grove, 1992. | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Introduction and definitions |
| Week 2 | Recombinant DNA technology |
| Week 3 | Cell kultures, fermentations and bioreactor systems |
| Week 4 | Small molecular biopharmaceuticals |
| Week 5 | Peptide-protein pharmaceuticals |
| Week 6 | Vaccines, recombinant vaccines, DNA vaccines |
| Week 7 | Monoclonal antibodies |
| Week 8 | Pharmaceuticals used in gene theraphy |
| Week 9 | Analytical methods used in Pharmaceutical Biotechnology |
| Week 10 | Regulatory issues |
| Week 11 | Licencing |
| Week 12 | Midterm exam |
| Week 13 | Homework |
| Week 14 | Discussion |
| Week 15 | Final exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 14 | 15 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 1 | 20 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 1 | 20 |
| Final exam | 1 | 45 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 55 | 55 |
| Percentage of final exam contributing grade succes | 45 | 45 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 1 | 14 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 1 | 14 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 1 | 10 | 10 |
| Midterms (Study duration) | 1 | 10 | 10 |
| Final Exam (Study duration) | 1 | 0 | 0 |
| Total Workload | 31 | 22 | 48 |
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 | X | ||||
| 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 | X | ||||
| 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 | |||||
| 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. | |||||
| 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. | |||||
| 14. Has basic and technical knowledge about radiopharmacy and has foreknowledge required for prepartio of license dossier of radiopharmaceuticals about radiopharmacy. | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest