| Course Type | Elective Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 5 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Knows the general separation methods. Knows the methods used in drug analysis and the selection of these methods.
- Know sampling and preparation of drug samples for analysis and analytical validation methods.
- Knows analytical method validation parameters and their statistical evaluation.
- Knows the guidelines and standards about analytical method validation.
- System compatibility tests can be done.
- Apply the methods and analytical method validation parameters in drug analysis in different environments in different laboratories.
- Develop a new method for the analysis of drugs and apply validation parameters in this method.
- Evaluates the results and prepares a report.
- Can use the information learned in this course in the fields of business after graduation.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | Selection of Methods Used in Drug Analysis Defining and evaluating the parameters required for analytical methods to be valid. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
General separation methods, Methods Used in Drug Analysis, Selection of Methods Used in Drug Analysis |
|
2nd Week |
Sampling and Preparation of Drug Samples for Analysis, Analytical measurement methods, Analytical Validation |
|
3rd Week |
Method transfer and re-validation |
|
4th Week |
Error types, Confidence interval, Calibration methods |
|
5th Week |
System compliance |
|
6th Week |
Parameters for method validation |
|
7th Week |
Middle Exam |
|
8th Week |
Parameters for method validation |
|
9th Week |
Analytical meaning of statistical parameters and their values |
|
10th Week |
Acceptance criteria for validation parameters in various systems |
|
11th Week |
Guidelines for Validation of Analytical Methods |
|
12th Week |
Evaluation of validation results and report preparation |
|
13th Week |
Application of validation parameters to drug analysis |
|
14th Week |
Application of validation parameters to drug analysis |
|
| Recommended or Required Reading | 1. ICH Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology Q2 (R1) Step 4 Version, 2005.
2. Validation of test methods, EAL publication (EAL-P11) 1997.
3. OTHER RELATED RECENT GUIDES, PAPERS AND BOOKS
|
|---|
| Planned Learning Activities and Teaching Methods |
- Lecture
- Discussion
- Problem Solving
|
|---|
| Assessment Methods and Criteria |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
0 |
0 |
0 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
3 |
42 |
| Preparation for Final exam |
1 |
30 |
30 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
0 |
0 |
0 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
3 |
15 |
45 |
| Literature review |
14 |
3 |
42 |
| Performance Practice |
14 |
1 |
14 |
| Total Work Load | 203 |
| Total Work Load / 30 (h) | 6.76 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
