Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| LABORATORY APPLICATIONS in PHR. INDUSTRY | - | Spring Semester | 4+0 | 4 | 6 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Assist.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Prof.Dr. Sevim ROLLAS |
| Assistant(s) | |
| Aim | To inform students about the processes in laboratory practices in the pharmaceutical industry. |
| Course Content | This course contains; 1.ICH, EMA, FDA, GMP, GLP and Pharmacopeias,2.Development of APIs.,3.Analytical Tests and Manufacturing of Raw Materials,4.Validation and Calibration,5.Electhrophoretic Methods (Gel, Capillar),6.Spectroscopic methods (UV, IR),7.Chromatographic Methods (HPLC),8.Development of Chromatographic Methods (HPLC),9.Preformulation Studies and Development of new formulations,10.Preformulation Studies and Development of new formulations,11.Pharmacopeia tests applied on Drug Formulations,12.Stability Tests,13.Quality by Design (QbD),14.Process Analytical Technologies (PAT). |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. Evaluate international organization and instruction terms like, ICH, EMA, FDA, GMP, GLP and pharmacopeia. | 17, 19, 9 | E, F |
| 1.1. Recognizes the organizations of ICH, EMA and FDA | 12, 18, 19, 9 | E, F |
| 1.2. Explains GMP and GLP guidelines. | 19, 9 | E, F |
| 1.3. Lists the type and specilities of pharmacopeas. | 12, 19, 2, 9 | E, F |
| 2. Distinguish development, manufacturing and analyzing of APIs. | 13, 17, 19, 9 | E, F |
| 2.1. Explains the process of API’s development. | 14, 17, 19, 2, 9 | E |
| 2.2. Recognizes manufacturing of APIs and impurity controls. | 19, 9 | E, F |
| 2.3. Summarizes the parameters of validation and calibration. | 12, 19, 9 | E, F |
| 2.4. Distinguishes the methodologies of chromatography, spectroscopy and electrophoresis in pharmaceutical industry. | 17, 19, 9 | E, F |
| 3. Plan the studies on formulation and tests of pharmacopeia. | 17, 19, 9 | E, F |
| 3.1. Plans the methodologies of chromatography in formulation and pharmacopeia analyzes. | 12, 19, 2, 9 | E, F |
| 3.2. Applies the devices of chromatography in formulation and pharmacopeia analyzes. | 17, 19, 9 | E, F |
| 3.3. Applies the devices of spectroscopy in formulation and pharmacopeia analyzes. | 17, 19, 9 | E, F |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 14: Self Study Method, 17: Experimental Technique, 18: Micro Teaching Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 9: Lecture Method |
| Assessment Methods: | E: Homework, F: Project Task |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1.ICH, EMA, FDA, GMP, GLP and Pharmacopeias | 1,2 |
| 2 | 2.Development of APIs. | 1,2 |
| 3 | 3.Analytical Tests and Manufacturing of Raw Materials | 1,2 |
| 4 | 4.Validation and Calibration | 1,2 |
| 5 | 5.Electhrophoretic Methods (Gel, Capillar) | 1,2 |
| 6 | 6.Spectroscopic methods (UV, IR) | 1,2 |
| 7 | 7.Chromatographic Methods (HPLC) | 1,2 |
| 8 | 8.Development of Chromatographic Methods (HPLC) | 1,2 |
| 9 | 9.Preformulation Studies and Development of new formulations | 1,2 |
| 10 | 10.Preformulation Studies and Development of new formulations | 1,2 |
| 11 | 11.Pharmacopeia tests applied on Drug Formulations | 1,2 |
| 12 | 12.Stability Tests | 1,2 |
| 13 | 13.Quality by Design (QbD) | 1,2 |
| 14 | 14.Process Analytical Technologies (PAT) | 1,2 |
| Resources |
| 1-Lesson materials will be given to students. |
| 2-ICH Guidelines (Q2, Q4, Q7, Q8, Q9, Q11) |
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. | X | |||||
| 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. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 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. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | X | |||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | X | |||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 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. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
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 | 4 | 56 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 7 | 6 | 42 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 2 | 10 | 20 | |||
| Quiz | 2 | 2 | 4 | |||
| Midterm Exam | 1 | 16 | 16 | |||
| General Exam | 1 | 30 | 30 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 168 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(168/30) | 6 | |||||
| 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 |
|---|---|---|---|---|---|
| LABORATORY APPLICATIONS in PHR. INDUSTRY | - | Spring Semester | 4+0 | 4 | 6 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Assist.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Prof.Dr. Sevim ROLLAS |
| Assistant(s) | |
| Aim | To inform students about the processes in laboratory practices in the pharmaceutical industry. |
| Course Content | This course contains; 1.ICH, EMA, FDA, GMP, GLP and Pharmacopeias,2.Development of APIs.,3.Analytical Tests and Manufacturing of Raw Materials,4.Validation and Calibration,5.Electhrophoretic Methods (Gel, Capillar),6.Spectroscopic methods (UV, IR),7.Chromatographic Methods (HPLC),8.Development of Chromatographic Methods (HPLC),9.Preformulation Studies and Development of new formulations,10.Preformulation Studies and Development of new formulations,11.Pharmacopeia tests applied on Drug Formulations,12.Stability Tests,13.Quality by Design (QbD),14.Process Analytical Technologies (PAT). |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. Evaluate international organization and instruction terms like, ICH, EMA, FDA, GMP, GLP and pharmacopeia. | 17, 19, 9 | E, F |
| 1.1. Recognizes the organizations of ICH, EMA and FDA | 12, 18, 19, 9 | E, F |
| 1.2. Explains GMP and GLP guidelines. | 19, 9 | E, F |
| 1.3. Lists the type and specilities of pharmacopeas. | 12, 19, 2, 9 | E, F |
| 2. Distinguish development, manufacturing and analyzing of APIs. | 13, 17, 19, 9 | E, F |
| 2.1. Explains the process of API’s development. | 14, 17, 19, 2, 9 | E |
| 2.2. Recognizes manufacturing of APIs and impurity controls. | 19, 9 | E, F |
| 2.3. Summarizes the parameters of validation and calibration. | 12, 19, 9 | E, F |
| 2.4. Distinguishes the methodologies of chromatography, spectroscopy and electrophoresis in pharmaceutical industry. | 17, 19, 9 | E, F |
| 3. Plan the studies on formulation and tests of pharmacopeia. | 17, 19, 9 | E, F |
| 3.1. Plans the methodologies of chromatography in formulation and pharmacopeia analyzes. | 12, 19, 2, 9 | E, F |
| 3.2. Applies the devices of chromatography in formulation and pharmacopeia analyzes. | 17, 19, 9 | E, F |
| 3.3. Applies the devices of spectroscopy in formulation and pharmacopeia analyzes. | 17, 19, 9 | E, F |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 14: Self Study Method, 17: Experimental Technique, 18: Micro Teaching Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 9: Lecture Method |
| Assessment Methods: | E: Homework, F: Project Task |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1.ICH, EMA, FDA, GMP, GLP and Pharmacopeias | 1,2 |
| 2 | 2.Development of APIs. | 1,2 |
| 3 | 3.Analytical Tests and Manufacturing of Raw Materials | 1,2 |
| 4 | 4.Validation and Calibration | 1,2 |
| 5 | 5.Electhrophoretic Methods (Gel, Capillar) | 1,2 |
| 6 | 6.Spectroscopic methods (UV, IR) | 1,2 |
| 7 | 7.Chromatographic Methods (HPLC) | 1,2 |
| 8 | 8.Development of Chromatographic Methods (HPLC) | 1,2 |
| 9 | 9.Preformulation Studies and Development of new formulations | 1,2 |
| 10 | 10.Preformulation Studies and Development of new formulations | 1,2 |
| 11 | 11.Pharmacopeia tests applied on Drug Formulations | 1,2 |
| 12 | 12.Stability Tests | 1,2 |
| 13 | 13.Quality by Design (QbD) | 1,2 |
| 14 | 14.Process Analytical Technologies (PAT) | 1,2 |
| Resources |
| 1-Lesson materials will be given to students. |
| 2-ICH Guidelines (Q2, Q4, Q7, Q8, Q9, Q11) |
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. | X | |||||
| 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. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 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. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | X | |||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | X | |||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 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. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |