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| ECZ4027 | Analytical Validation in Drug Analysis | 2+0+0 | ECTS:4 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 2 hours of lectures per week | | Lecturer | Doç. Dr. Fatma AĞIN | | Co-Lecturer | Assoc. Prof. Dr. Fatma AĞIN, 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 the validation parameters used in drug analysis, to teach the knowledge and skills necessary to interpret and report validation results. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Learns validation and its importance. | 5 | 1, | | LO - 2 : | Learns the parameters used in the validation calculations. | 5 | 1, | | LO - 3 : | Learn to interpret the results of validation parameters. | 5 | 1, | | LO - 4 : | Learns to report the resulting validation results and share them with the related people. | 5 | 1, | | 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), LO : Learning Outcome | | |
| Analytical validation and importance of validation in drug analysis, statistical parameters used in calculation of validation parameters, validation parameters, reporting of validation results and examination of samples. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | What is validation? What are validation parameters? | | | Week 2 | Statistical validation parameters | | | Week 3 | Sampling and Preparation | | | Week 4 | Preparation of Drug Samples for Analysis | | | Week 5 | Validation and Inter-Laboratory Method Transfer | | | Week 6 | Validation and Inter-Laboratory Method Transfer | | | Week 7 | Validation of Analytical Analysis and Experimental Methods in Pharmaceutical Laboratories | | | Week 8 | Validation of Analytical Analysis and Experimental Methods in Pharmaceutical Laboratories | | | Week 9 | Mid-term examination | | | Week 10 | Validation of Analytical Analysis and Experimental Methods in Pharmaceutical Laboratories | | | Week 11 | Analytical Meaning of Statistical Parameters and Values | | | Week 12 | Analytical Meaning of Statistical Parameters and Values | | | Week 13 | Guidelines for Validation of Analytical Methods | | | Week 14 | Guidelines for Validation of Analytical Methods | | | Week 15 | Guidelines for Validation of Analytical Methods | | | Week 16 | Final examination | | | |
| 1 | Analitik metodların geliştirilmesi ve validasyonu, Aydın, H. 2016; Gazi Kitabevi, Ankara. | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 25/11/2021 | 1 | 50 | | End-of-term exam | 16 | 12/01/2022 | 1 | 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 | 2 | 14 | 28 | | Arasınav için hazırlık | 5 | 5 | 25 | | Arasınav | 2 | 1 | 2 | | Dönem sonu sınavı için hazırlık | 8 | 6 | 48 | | Dönem sonu sınavı | 2 | 1 | 2 | | Total work load | | | 105 |
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