EAG609 - METHODS USED IN PHARMACEUTICAL and BIOPHARMACEUTIC
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| METHODS USED IN PHARMACEUTICAL and BIOPHARMACEUTIC | EAG609 | Any Semester/Year | 3 | 0 | 3 | 5 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Problem Solving | |||||
| Instructor (s) | Prof. Dr. INCILAY SÜSLÜ, Doç. Dr. MUSTAFA ÇELEBIER,Doç. Dr. AYSEGÜL DOGAN | |||||
| Course objective | To gain knowledge of chromatographic analysis methods used in the pharmaceutical industry and development of these methods and application to drug analysis | |||||
| Learning outcomes |
| |||||
| Course Content | Introduction to chromatography, Introduce of basic concepts, Classification of chromatography, Planar chromatography, Column chromatography, Gas chromatography, High performance liquid chromatography, Mathematical parameters in chromatography, Development of chromatographic method, application of chromatographic methods in pharmaceutical and biopharmaceutical analysis, Interpretation of chromatographic results, Problems encountered in chromatographic methods and solutions. | |||||
| References | 1. D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch, Analitik Kimya Temel İlkeler, 1. Cilt, Çeviri Editörleri: Esma Kılıç, Hamza Yılmaz, 8. Baskı, Bilim Yayınları, 2007. 2. D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch, Fundamentals of Analytical Chemistry, Eighth Edition, Brooks Cole, 2004. 3. D.C. Harris, Quantitative Chemical Analysis, Seventh Edition, W.H. Freeman and Company, USA, 2007. 4. OTHER RELATED RECENT GUIDES, PAPERS AND BOOKS | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Introduction to chromatography, introduce of basic concepts |
| Week 2 | Planar and column chromatographic techniques |
| Week 3 | Systems of stationary phase - mobile phase |
| Week 4 | Gas chromatography - columns, enjection systems, dedectors |
| Week 5 | High performance liquid chromatography, columns, enjection systems |
| Week 6 | High performance liquid chromatography, pump systems, detectors |
| Week 7 | Midterm exam |
| Week 8 | Mathematical parameters in chromatography and assessment |
| Week 9 | Development of chromatographic method in drug analysis |
| Week 10 | Selection of appropriate chromatographic method in drug analysis and its application |
| Week 11 | Evaluation of chromatographic results obtained from drug analysis and its interpretation |
| Week 12 | Development of gas chromatography techniques, problems encountered in application and solutions. |
| Week 13 | Development of liquid techniques, problems encountered in application and solutions. |
| Week 14 | GC- combine chromatographic techniques used in drug analysis |
| Week 15 | LC- combine chromatographic techniques used in drug analysis |
| 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 | 3 | 4 | 12 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 7 | 4 | 28 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 28 | 28 |
| Final Exam (Study duration) | 1 | 40 | 40 |
| Total Workload | 26 | 79 | 150 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has knowledge in the area of preformulation and formulation designs about industrial production, quality control, quality assurance system and stability | X | ||||
| 2. Acquires information about nanotechnology, new drug delivery systems and controlled release systems | |||||
| 3. Learns to keep track of up to date literature and patents using the knowledge and informatics technologies | X | ||||
| 4. Interprets the guidelines of health authorities such as FDA, EMA and international guidelines such as GMP, ANDA, BA/BE, QA/QC, acquires application knowledge and skills | X | ||||
| 5. Has knowledge to understand and interpret chemical, instrumental and pharmacological data | |||||
| 6. Has basic concepts about medicinal chemistry such as design of new drug molecules, drug-receptor interactions | |||||
| 7. Has the knowledge on the rules of scientific ethics which should be complied | X | ||||
| 8. Effectively uses the conventional and new synthetic methods. | |||||
| 9. Has knowledge of advanced toxicity tests accepted by regulatory authorities | |||||
| 10. Has knowledge about pharmacological experimental methods and their applications used in drug research and evaluates analysis results | |||||
| 11. Has knowledge about preclinical and clinical drug research | |||||
| 12. Has knowledge about the pharmacokinetic and pharmacodynamic properties of drugs | X | ||||
| 13. Has knowledge about the pharmacokinetics and pharmacodynamics of drugs | X | ||||
| 14. Has knowledge of and the ability to use the devices and instruments used in the application of instrumental analysis methods | X | ||||
| 15. Has the ability to apply theoretical and practical knowledge in the analysis of substances in medicinal products and biological materials | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest