|
|
| EAK5011 | Evaluation of Analysis Results in Pharmacy | 3+0+0 | ECTS:7.5 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | ANALYTICAL CHEMISTRY IN PHARMACY | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 3 hours of lectures per week | | Lecturer | -- | | Co-Lecturer | Dr. Lecturer Fatma AĞIN, Assoc.Prof. Dr. Dilek KUL | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | The aim of this course is to teach how to evaluate the results obtained during the analysis of pharmaceutical active ingredients in pharmaceuticals and biological samples (blood and urine exc.). Thus, students will effectively use these methods used in the industry and scientific laboratories. |
| Programme Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | PO - 1 : | Have information on how to interpret of analysis results obtained experimentally. | 3,4,12 | 1,3, | | PO - 2 : | Have information on validation methods. | 3,4,12 | 1,3, | | PO - 3 : | Have information on accuracy and reliability of the analysis results. | 3,4,12 | 1,3, | | PO - 4 : | Have information on statistical evaluation of the analysis results. | 3,4,12 | 1,3, | | PO - 5 : | Learn how to compare these methods using the results obtained from different analysis methods. | 3,4,12 | 1,3, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), PO : Learning Outcome | | |
| It includes the evaluation of the results obtained from various analysis methods used for drugs in laboratories. |
| |
| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | General identification of analysis methods used in pharmaceuticals | | | Week 2 | Validation methods used in evaluation of the analysis methods | | | Week 3 | Method validation approaches | | | Week 4 | Precision, accuracy, and sensitivity of the analysis results | | | Week 5 | Determination of limit of detection and limit of quantitation and their interpretation | | | Week 6 | Drawn of the calibration graphs, determination of linear operating range, confidence interval and their evaluation | | | Week 7 | Reproducibility, selection of outliers from the analysis results and their removal from the calculations | | | Week 8 | Rounding of the analysis results and statistical comparison | | | Week 9 | Mid-term exam | | | Week 10 | Standard deviation, relative standard deviation, strenght and durability | | | Week 11 | System suitability tests | | | Week 12 | Evaluation of the analysis results of different methods using literature | | | Week 13 | Evaluation of the analysis results of different methods using literature | | | Week 14 | Usage of validation methods from the example data | | | Week 15 | Summarize of the validation methods and new metod production | | | Week 16 | End-of-term exam | | | |
| 1 | Ermer, Joachim; Miller, John H. McB. 2005; Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, Wiley-VCH. | | | |
| 1 | Ozkan,Sibel A. 2011; Electroanalytical Methods in Pharmaceutical Analysis and Their Validation, H N B Pub. | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 15/04/2024 | 2 | 30 | | In-term studies (second mid-term exam) | 15 | 01/06/2024 | 1 | 20 | | End-of-term exam | 16 | 03/06/2024 | 2 | 50 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 3 | 14 | 42 | | Arasınav için hazırlık | 8 | 2 | 16 | | Arasınav | 2 | 1 | 2 | | Dönem sonu sınavı için hazırlık | 8 | 8 | 64 | | Dönem sonu sınavı | 2 | 1 | 2 | | Diğer 1 | 8 | 8 | 64 | | Total work load | | | 190 |
|