| Course Type | Elective Course |
|---|
| Course Level | Bachelor's Degree |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 2 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Analytical measurement methods used in Analytical Chemistry knows numerical criteria and other features in method selection.
- Analytical Meaning of Statistical Parameters and Values and evaluate analytical data.
- Knows what is the validation of an analytical method, how and when it should be done and what is partial validation.
- Knows the definition of accuracy, precision, (repeatability), and reality parameters among the parameters for method validation.
- Calibration and linearity can be calculated. It can select the measurement range, sensitivity (lower and upper detection limit, limit of observability,), working range.
- Knows the definitions of regression and correlation. Stability, specificity, selectivity.Knows the definition of recovery, rubutness, ruggetness,consistency parameters and can calculate.
- Make the determination and comparison of validity indicators.
- Follow Method Validation Practices in Drug Analysis
- Can use the information learned in this course in the fields of business after graduation.
|
| Mode of Delivery | Face to face |
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| Prerequisites | No |
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| Recommended Optional Programme Components | None |
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| Course Description | Analytical measurement methods used in drug analysis and the parameters required for analytical methods to be valid and the statistical evaluation and application of these parameters. |
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| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Analytical measurement methods used in Analytical Chemistry |
|
2nd Week |
Numerical criteria and other features in method selection |
|
3rd Week |
Analytical Meaning of Statistical Parameters and Their Values, Evaluation of analytical data |
|
4th Week |
What is the validation of an analytical method? How and in what situations should it be done? What is partial validation? |
|
5th Week |
Introduction to parameters for method validation |
|
6th Week |
Accuracy, Precision, (Repeatability), reality |
|
7th Week |
Midterm exam |
|
8th Week |
Calibration and Linearity, measurement range, Sensitivity (Lower and upper detection limit, observability limit,), Working range |
|
9th Week |
Regression and correlation |
|
10th Week |
Stability, Originality, Selectivity |
|
11th Week |
Recovery, rubustness,ruggetness |
|
12th Week |
Determination and comparison of validity indicators |
|
13th Week |
Validation Applications in Drug Analysis |
|
14th Week |
Validation Applications in Drug Analysis |
|
| Recommended or Required Reading | 1. Sümbüloğlu, K., Sümbüloğlu, V., Biyoistatistik, Hatipoğlu Yayınevi, 7. Baskı, Ankara, 1997.
2. Validation of analytical procedures: Methodology. ICH Harmonised Tripartite Guideline, ICH Steering Committee, 1996.
3. ICH Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology Q2 (R1) Step 4 Version, 2005.
4. Green, J.M., A practical guide to analytical method validation. Analytical Chemistry, 68, 305A-309A, 1996.
5. OTHER RELATED RECENT GUIDES, PAPERS AND BOOKS
|
|---|
| Planned Learning Activities and Teaching Methods |
- Lecture
- Discussion
- Problem Solving
|
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| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
40 |
| Assignment |
1 |
10 |
| Total(%) |
|
50 |
| Contribution of In-term Studies to Overall Grade(%) |
|
50 |
| Contribution of Final Examination to Overall Grade(%) |
|
50 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
1 |
1 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
1 |
14 |
| Preparation for Final exam |
1 |
8 |
8 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
4 |
4 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
1 |
4 |
4 |
| Total Work Load | 61 |
| Total Work Load / 30 (h) | 2.03 |
| ECTS Credit of the Course | 2 |
|
| Language of Instruction | Turkish |
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| Work Placement(s) | No |
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