| 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;
- Know R studies in the development of a new and generic formulations
- Know knowledge of cell culture and in silico models during drug development.
- Know the basic principles of scale up studies.
- Make the scale up studies in different drug forms.
- Know the general rules and requirements of production in pilot and industrial scale.
- Use the acquired knowledge and skills in the pharmaceutical industry and other institutions.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | R&D studies carried out in the development of new and generic drug forms in the pharmaceutical industry include the rules of scaling up in different drug forms, general rules and requirements of pilot and industrial production. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
The importance of R&D studies in new and generic drug development processes |
|
2nd Week |
Selection of candidate drug and excipients |
|
3rd Week |
R&D studies in formulations developed for oral administration |
|
4th Week |
The importance of dissolution studies in the development of oral solid drug forms, biowaiver |
|
5th Week |
Cell culture studies and its importance in terms of biowaivers |
|
6th Week |
Importance of impurity in drug development |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Pilot production design and requirements |
|
9th Week |
In silico models in drug development |
|
10th Week |
The purpose and similarity principles of scale-up studies |
|
11th Week |
Increasing batch size in Pharmaceutical unit processes (mixing, dry milling, drying etc.) |
|
12th Week |
Scale up in solid drug forms (tablet, capsule) |
|
13th Week |
Scale up in liquid, semi-solid drug forms |
|
14th Week |
The basic rules of industrial production |
|
| Recommended or Required Reading | 1. Lecturer notes
2. Pharmaceutical Process Scale-Up (Drugs and the Pharmaceutical Sciences), Ed: M Levin, Marcel Dekker Inc., New York, 2001. |
|---|
| Planned Learning Activities and Teaching Methods |
- Teorik
- interaktif anlatım
- tartışma
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
30 |
| Assignment |
2 |
20 |
| 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 |
0 |
0 |
0 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
3 |
42 |
| Preparation for Final exam |
1 |
18 |
18 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
0 |
0 |
0 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
3 |
3 |
| Homework |
2 |
13 |
26 |
| Presentation (including preperation) |
2 |
14 |
28 |
| Literature review |
14 |
3 |
42 |
| Performance Practice |
14 |
1 |
14 |
| Total Work Load | 201 |
| Total Work Load / 30 (h) | 6.7 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
