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| EAK6009 | Validation and Accredit. in Analy. Chem. | 3+0+0 | ECTS:7.5 | | Year / Semester | Fall Semester | | Level of Course | Third Cycle | | Status | Compulsory | | 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 | | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | This course aims to teach the validation of instrumental analytical methods used in pharmacy. With this course, the student will be able to develop an analytical method for the quantitative determination of many substances used in pharmaceuticals, such as drug active ingredients, learn how to validate and apply the method developed. |
| Programme Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | PO - 1 : | Learn the purpose of analytical method validation. | 3,10 | 1,3, | | PO - 2 : | Learn the validation parameters and their calculations. | 3,10 | 1,3, | | PO - 3 : | Learn to analyze and evaluate data by associating it with the subject. | 3,10 | 1,3, | | PO - 4 : | Gain the ability to have professional competence related to the course and to monitor and interpret current topics. | 3,10 | 1,3, | | PO - 5 : | Use the course content to evaluate current topics. | 3,10 | 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 | | |
| Analytical method validation, validation parameters, calculations and accreditation. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | What is analytical methods? | | | Week 2 | How to develop analytical methods? | | | Week 3 | Validation parameters | | | Week 4 | Analytical validation of pharmaceuticals | | | Week 5 | Analytical validation of pharmaceuticals | | | Week 6 | Calculations of validation parameters and validation tests | | | Week 7 | Calculations of validation parameters and validation tests | | | Week 8 | Qualification of analytical equipment | | | Week 9 | Mid-term exam | | | Week 10 | Qualification of analytical equipment | | | Week 11 | Validation during drug product development | | | Week 12 | Validation during drug product development | | | Week 13 | Analytical procedures in quality control | | | Week 14 | Future trends in analytical method validation | | | Week 15 | Accreditation concept and its applications | | | Week 16 | Final exam | | | |
| 1 | D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch, Fundamentals of Analytical Chemistry, 8th Ed., Thompson-Brooks/Cole, 2004. | | | 2 | J. Ermer, J.H.McB. Miller, Method Validation in Pharmaceutical Analysis, Wiley-VCH, Germany, 2004. | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 25/11/2023 | 1 | 30 | | In-term studies (second mid-term exam) | 15 | 10/01/2024 | 1 | 20 | | End-of-term exam | 16 | 15/01/2024 | 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 | 3 | 14 | 42 | | Arasınav için hazırlık | 3 | 9 | 27 | | Arasınav | 2 | 1 | 2 | | Dönem sonu sınavı için hazırlık | 3 | 15 | 45 | | Dönem sonu sınavı | 2 | 1 | 2 | | Diğer 1 | 5 | 15 | 75 | | Total work load | | | 193 |
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