ERF610 - QUALITY CONTROL of RADIOPHARMACEUTICALS
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| QUALITY CONTROL of RADIOPHARMACEUTICALS | ERF610 | Any Semester/Year | 3 | 0 | 3 | 8 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion | |||||
| Instructor (s) | Prof. Dr. Suna ErdoÄŸan | |||||
| Course objective | The course aim is to teach quality control tests of radiopharmaceuticals (i.e. Radiochemical purity, radionuclidic purity, radioassay, pyrogenicity, sterility). | |||||
| Learning outcomes |
| |||||
| Course Content | - Nuclear regulations, pharmacopeia, NRC and FDA regulations - Characteristics of ideal radiopharmaceuticals - Problems specific to radiopharmaceuticals - Quality control tests carried on radiopharmaceuticals; radionuclidic purity - Quality control tests carried on radiopharmaceuticals; chemical and radiochemical purity - Quality control tests carried on radiopharmaceuticals; sterility test, pyrogen test, biodistribution and toxicity tests - Quality control tests carried on dose calibrators, Mo-99/Tc-99m generators - Examples for radiopharmaceuticals used in clinic; Tc-99m-radiopharmaceuticals - Examples of radiopharmaceuticals used in clinic; radioiodinated radiopharmaceuticals - Examples of radiopharmaceuticals used in clinic; PET radiopharmaceuticals - Examples of radiopharmaceuticals used in clinic; radiopharmaceuticals labeled with other radionuclides | |||||
| References | 1- Gopal B. Saha, Fundamentals of Nuclear Pharmacy, New York, springer, 2004. 2- IAEA TEC DOC , Production of 99mTc-Radiopharmaceuticals for Brain, Heart, Kidney Imaging, 1995. 3- IAEA TEC DOC 649, Preparation Kits for 99mTc Radiopharmaceuticals, 1992. | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Nuclear regulations, pharmacopeia, NRC and FDA regulations |
| Week 2 | Characteristics of ideal radiopharmaceuticals |
| Week 3 | Problems specific to radiopharmaceuticals |
| Week 4 | Quality control tests carried on radiopharmaceuticals; radionuclidic purity |
| Week 5 | Quality control tests carried on radiopharmaceuticals; chemical and radiochemical purity, chromatography methods (ITLC-SG/SA) |
| Week 6 | Quality control tests carried on radiopharmaceuticals; sterility test, pyrogen test |
| Week 7 | Midterm exam |
| Week 8 | Quality control tests carried on radiopharmaceuticals; biodistribution and toxicity tests |
| Week 9 | Quality control tests carried on dose calibrators, Mo-99/Tc-99m generators |
| Week 10 | Examples of radiopharmaceuticals used in clinic; Tc-99m-radiopharmaceuticals |
| Week 11 | Examples of radiopharmaceuticals used in clinic; radioiodinated radiopharmaceuticals |
| Week 12 | Examples of radiopharmaceuticals used in clinic; PET radiopharmaceuticals |
| Week 13 | Examples of radiopharmaceuticals used in clinic; radiopharmaceuticals labeled with other radionuclides |
| Week 14 | Examples of radiopharmaceuticals used in clinic; radiopharmaceuticals labeled with other radionuclides |
| Week 15 | Arrangements for final exam |
| Week 16 | 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 | 1 | 50 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 50 |
| Percentage of final exam contributing grade succes | 1 | 50 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 3 | 42 |
| 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 | 3 | 42 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 66 | 66 |
| Final Exam (Study duration) | 1 | 70 | 70 |
| Total Workload | 30 | 142 | 220 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Searches current information in his field. Knows how to conduct scientific research and access information sources, and evaluates and uses this information. | |||||
| 2. Designs, carries out and evaluates scientific studies using theoretical and practical knowledge at the level of expertise acquired in that field. | X | ||||
| 3. Performs statistical analysis and interpretation of data obtained from studies. | X | ||||
| 4. Presents the results obtained from scientific studies in scientific meetings, prepare the reports of results and publishes the results of studies in national and/or international journal. | |||||
| 5. Has the theoretical knowledge and appropriate skills on formulation, manufacturing, stability, quality assurance, regulatory affairs, and other regulations and distributions of radiopharmaceuticals. | X | ||||
| 6. Has the knowledge on effect of radiation on pharmaceutics, cosmetics and their raw materilas, drug delivery systems and medical devices and know how to control and/or prevent the possible changes occured by gamma irradiation. | |||||
| 7. Knows the biological effect of ionized radiation. Follow the rules required for radiation protection to protect the radiation worker, public and environment. | |||||
| 8. Applies the principles of GMP and GRP in whole process of life cycle of radiopharmacuticals. | |||||
| 9. Applies principles of professional development and lifelong learning, communication and social skills on professional practices. | |||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest