Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| R&D in PHARMACY | - | Fall Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | Have knowledge about how R&D studies in pharmaceutical industries are performed. |
| Course Content | This course contains; 1. Definition and history of R&D,2. Basic researches,3. Basic researches,4. Applied researches,5. Applied researches,6. Experimental development,7. Experimental development,8. İnnovation in pharmaceutical industries,9. Innovation studies about development of new pharmaceutical active substances,10. Innovation studies about development of new pharmaceutical forms,11. R&D in pharmacy and university, industry and government cooperation,12. R&D expenditures,13. National incentive programs and politics for R&D,14. National incentive programs and politics for R&D. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. will be able to debate definition of R&D and compare research-development methods. | 19, 2, 9 | E |
| 1.1. explains R&D. | 19, 9 | E |
| 1.2. summarizes history of R&D. | 19, 9 | E |
| 1.3. interprets basic and applied researches. | 19, 9 | E |
| 1.4. questions experimental development methods. | 19, 9 | E |
| 2. will be able to debate innovation in pharmaceutical industries and its impact on university and state cooperation. | 19, 9 | E |
| 2.1. explains innovation in pharmaceutical industries. | 19, 9 | E |
| 2.2. interprets innovation studies about development of new pharmaceutics. | 13, 19, 9 | E |
| 2.3. summarizes university and government cooperation in R&D studies. | 19, 9 | E |
| 3. will be able to debate R&D expenditure and national politics. | 12, 19, 9 | E |
| 3.1. explains R&D expenditures. | 19, 9 | E |
| 3.2. interprets national incentive programs. | 19, 9 | E |
| 3.3. questions national politics in R&D studies. | 19, 9 | E |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 19: Brainstorming Technique, 2: Project Based Learning Model, 9: Lecture Method |
| Assessment Methods: | E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Definition and history of R&D | 1,2 |
| 2 | 2. Basic researches | 1,2 |
| 3 | 3. Basic researches | 1,2 |
| 4 | 4. Applied researches | 1,2,3 |
| 5 | 5. Applied researches | 1,2,3 |
| 6 | 6. Experimental development | 1,2,3 |
| 7 | 7. Experimental development | 1,2,3 |
| 8 | 8. İnnovation in pharmaceutical industries | 1,2,3,4 |
| 9 | 9. Innovation studies about development of new pharmaceutical active substances | 1,2,3 |
| 10 | 10. Innovation studies about development of new pharmaceutical forms | 1,2,3 |
| 11 | 11. R&D in pharmacy and university, industry and government cooperation | 1,2 |
| 12 | 12. R&D expenditures | 1,2 |
| 13 | 13. National incentive programs and politics for R&D | 1 |
| 14 | 14. National incentive programs and politics for R&D | 1 |
| Resources |
| 1. Lecture notes will be given to the students. |
| 2. https://doi.org/10.1039/9781782620402-00001 3. Michael Levin,Process Scale-Up,2001 by Marcel Dekker, Inc 4. Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems,ICH |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 2 | 28 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 2 | 5 | 10 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 1 | 15 | 15 | |||
| General Exam | 1 | 25 | 25 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 78 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(78/30) | 3 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| R&D in PHARMACY | - | Fall Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Fatma Julide AKBUĞA |
| Name of Lecturer(s) | Prof.Dr. Fatma Julide AKBUĞA |
| Assistant(s) | |
| Aim | Have knowledge about how R&D studies in pharmaceutical industries are performed. |
| Course Content | This course contains; 1. Definition and history of R&D,2. Basic researches,3. Basic researches,4. Applied researches,5. Applied researches,6. Experimental development,7. Experimental development,8. İnnovation in pharmaceutical industries,9. Innovation studies about development of new pharmaceutical active substances,10. Innovation studies about development of new pharmaceutical forms,11. R&D in pharmacy and university, industry and government cooperation,12. R&D expenditures,13. National incentive programs and politics for R&D,14. National incentive programs and politics for R&D. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. will be able to debate definition of R&D and compare research-development methods. | 19, 2, 9 | E |
| 1.1. explains R&D. | 19, 9 | E |
| 1.2. summarizes history of R&D. | 19, 9 | E |
| 1.3. interprets basic and applied researches. | 19, 9 | E |
| 1.4. questions experimental development methods. | 19, 9 | E |
| 2. will be able to debate innovation in pharmaceutical industries and its impact on university and state cooperation. | 19, 9 | E |
| 2.1. explains innovation in pharmaceutical industries. | 19, 9 | E |
| 2.2. interprets innovation studies about development of new pharmaceutics. | 13, 19, 9 | E |
| 2.3. summarizes university and government cooperation in R&D studies. | 19, 9 | E |
| 3. will be able to debate R&D expenditure and national politics. | 12, 19, 9 | E |
| 3.1. explains R&D expenditures. | 19, 9 | E |
| 3.2. interprets national incentive programs. | 19, 9 | E |
| 3.3. questions national politics in R&D studies. | 19, 9 | E |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 19: Brainstorming Technique, 2: Project Based Learning Model, 9: Lecture Method |
| Assessment Methods: | E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Definition and history of R&D | 1,2 |
| 2 | 2. Basic researches | 1,2 |
| 3 | 3. Basic researches | 1,2 |
| 4 | 4. Applied researches | 1,2,3 |
| 5 | 5. Applied researches | 1,2,3 |
| 6 | 6. Experimental development | 1,2,3 |
| 7 | 7. Experimental development | 1,2,3 |
| 8 | 8. İnnovation in pharmaceutical industries | 1,2,3,4 |
| 9 | 9. Innovation studies about development of new pharmaceutical active substances | 1,2,3 |
| 10 | 10. Innovation studies about development of new pharmaceutical forms | 1,2,3 |
| 11 | 11. R&D in pharmacy and university, industry and government cooperation | 1,2 |
| 12 | 12. R&D expenditures | 1,2 |
| 13 | 13. National incentive programs and politics for R&D | 1 |
| 14 | 14. National incentive programs and politics for R&D | 1 |
| Resources |
| 1. Lecture notes will be given to the students. |
| 2. https://doi.org/10.1039/9781782620402-00001 3. Michael Levin,Process Scale-Up,2001 by Marcel Dekker, Inc 4. Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems,ICH |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |