| Course Type | Elective Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 5 |
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| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Knows the importance of dissolution rate studies in drug development, bioavailability and bioequivalence and comparison of dissolution profiles.
- Learns the definitions of reference drug and generic drug, bioavailability, bioequivalence.
- Learns the basic information about the design and evaluation of bioavailability/bioequivalence studies, calculation of pharmacokinetic parameters.
- Learns information about Biopharmaceutical Classification System (BCS) and biowaiver with examples.
- Gains information about legal regulations (TITCK, EMA, FDA, WHO) related to bioavailability and bioequivalence,
- Health personnel, society and institutions with the knowledge and skills gained.
|
| 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 | This course; Basic concepts in biopharmaceuticals, definitions of bioavailability and bioequivalence, the importance of dissolution rate studies in drug development, the importance of bioavailability and bioequivalence and the comparison of dissolution profiles, bioavailability / bioequivalence study designs, bioequivalence biowaiver criteria and legal regulations on bioavailability and bioequivalence (TİTCK, EMA, FDA, WHO) covers. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Basic concepts, bioavailability and bioequivalence definitions in biopharmaceuticals |
|
2nd Week |
The importance of dissolution rate studies in drug development |
|
3rd Week |
Factors affecting the dissolution rate and methods for determining the dissolution rate |
|
4th Week |
The importance of dissolution studies in the development of oral solid drug forms, biowaiver |
|
5th Week |
Factors affecting the dissolution rate and methods for determining the dissolution rate |
|
6th Week |
Bioavailability and bioequivalence criteria, calculations, evaluations |
|
7th Week |
MIDTERM EXAMINATION |
|
8th Week |
Bioequivalence assessments in different dosage forms (such as immediate release, controlled release and fixed dose combinations, topical dosage forms) |
|
9th Week |
Bioequivalence assessments in different dosage forms (such as immediate release, controlled release and fixed dose combinations, topical dosage forms) |
|
10th Week |
Biopharmaceutical Classification System (BCS) and basic principles of biowaiver |
|
11th Week |
Biopharmaceutical Classification System (BCS) and basic principles of biowaiver |
|
12th Week |
Legal regulations on bioavailability and bioequivalence (TİTCK) |
|
13th Week |
Legal regulations on bioavailability and bioequivalence (EMA ) |
|
14th Week |
Legal regulations on bioavailability and bioequivalence (FDA, WHO) |
|
| Recommended or Required Reading | 1. Lecturer notes
2. Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi Yayını (Acartürk,F., Ağabeyoğlu,İ., Çelebi,N., Değim, T., Değim, Z.,Doğanay,T.,Takka,S., Tırnaksız,F.,),2009
3. J.G.Wagner, Fundamentals of Pharmacokinetics, Hamilton Press, Inc., Hamilton, Illinois 62341.
4. 5.Dissolution Bioavailability & Bioequivalence, Abdou, H.M. Marc Printing Company,
5. Guidlines, TİTCK, EMA, WHO ve FDA |
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| Planned Learning Activities and Teaching Methods |
- Teorik
- interaktif tartışma
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Assignment |
2 |
20 |
| Practice |
14 |
20 |
| Other |
2 |
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 |
0 |
0 |
0 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
2 |
28 |
| Preparation for Final exam |
1 |
14 |
14 |
| 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 |
12 |
24 |
| Presentation (including preperation) |
1 |
14 |
14 |
| Literature review |
12 |
3 |
36 |
| Total Work Load | 147 |
| Total Work Load / 30 (h) | 4.9 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
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| Work Placement(s) | No |
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