| 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;
- Learn the development process and stages of a new drug.
- Learn R&D studies in the development of a new and generic formulations
- Learn the pharmaceutical processes regarding to develop a new and generic formulation.
- Acquire knowledge about technology transfer.
- Learn the knowledge regarding to scale up process from lab scale to pilot and industrial scale
- Transfer the knowledge and skills gained in R&D studies to the pharmaceutical industry.
- Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life.
- Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
|
| 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 | It covers the importance of R&D studies in the pharmaceutical industry, R&D studies conducted in the development of new and generic drug forms, pharmaceutical scale up studies, technology transfer. |
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| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
The importance of R & D studies in pharmaceutical industry, the current situation in Turkey and in the world |
|
2nd Week |
Types of innovation in the pharmaceutical industry (incremental, stepwiswise,breakthrough) |
|
3rd Week |
The role of stakeholders (public, industry, university) in R&D and innovation |
|
4th Week |
New drug development process and stages |
|
5th Week |
R&D studies in the development of new and generic dosage formsformulation |
|
6th Week |
Basic rules in the selection of candidate drugs and excipients |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
The importance of cell culture studies in drug development |
|
9th Week |
In silico models in drug development |
|
10th Week |
Pharmaceutical scale-up studies in the development of new and generic product formulation |
|
11th Week |
Scale-up in solid dosage forms (Tablets, Capsules) |
|
12th Week |
Scale up in Parenteral dosage forms |
|
13th Week |
Scale up in demi solid dosage forms |
|
14th Week |
Technology transfer |
|
| 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. |
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| Planned Learning Activities and Teaching Methods |
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
40 |
| Total(%) |
|
40 |
| Contribution of In-term Studies to Overall Grade(%) |
|
40 |
| Contribution of Final Examination to Overall Grade(%) |
|
60 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| 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 |
6 |
6 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
1 |
5 |
5 |
| Total Work Load | 65 |
| Total Work Load / 30 (h) | 2.16 |
| ECTS Credit of the Course | 2 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
