ERU604 - TECHNOLOGICAL EVALUATIONS IN DRUG REGISTRATION
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| TECHNOLOGICAL EVALUATIONS IN DRUG REGISTRATION | ERU604 | Spring | 4 | 0 | 4 | 7 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Preparing and/or Presenting Reports | |||||
| Instructor (s) | Prof. Dr. Sevda Şenel, Prof.Dr. Selma Şahin, Prof.Dr. Betül Arıca-Yegin, Assist.Prof.Dr. T. Gülsün İnal | |||||
| Course objective | In the preparation and evaluation of drug registration documents, subjects of pharmaceutical technology have importance. The objective of this course is to teach students and give them the required perspective to follow the latest developments in the preparation of drug registration documents, evaluation and conclusion of the registrations steps. | |||||
| Learning outcomes |
| |||||
| Course Content | Preparation of registration sections, their evaluation from regulatory and technological aspects. | |||||
| References | Lecture notes, general references of Pharmaceutical Technology, articles, ICH guidelines, EC directives, FDA directives | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Preformulation and formulation development studies I |
| Week 2 | Preformulation and formulation development studies II |
| Week 3 | Manufacturing process and scale up |
| Week 4 | In vitro dissolution tests and evaluation related to pharmaceutical dosage forms |
| Week 5 | In vivo evaluations related to pharmacetical dosage forms |
| Week 6 | Standard operation process, validation and evaluation of production method |
| Week 7 | Licensing practices in the world |
| Week 8 | Authorized regulations on licensing process in the world |
| Week 9 | Finished product specifications-I |
| Week 10 | Finished product specifications-II |
| Week 11 | Stability studies and evaluation related to drug and finished product - I |
| Week 12 | Stability studies and evaluation related to drug and finished product - II |
| Week 13 | Good manufacturing practices-I |
| Week 14 | Good manufacturing practices-II |
| 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 | 1 | 25 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 1 | 25 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 50 |
| Percentage of final exam contributing grade succes | 0 | 0 |
| Total | 50 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 4 | 56 |
| 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 | 4 | 56 |
| Presentation / Seminar Preparation | 1 | 18 | 18 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 30 | 30 |
| Final Exam (Study duration) | 1 | 50 | 50 |
| Total Workload | 31 | 106 | 210 |
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 | X | ||||
| 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 | X | ||||
| 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 | X | ||||
| 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. | X | ||||
| 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. | X | ||||
| 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. | X | ||||
| 13. Capable to discuss and/or defend pharmacoeconomic data in medicine licensing. | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest