| Course Type | Compulsory Course |
|---|
| Course Level | Bachelor's Degree |
|---|
| Year of Study | 4 |
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| Semester | Eighth Term (Spring) |
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| ECTS | 3 |
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| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Have knowledge about the basic concepts of dissolution rate and dissolution rate kinetics and the importance of dissolution in drug development and comparison of dissolution profiles.
- Learn the basic concepts in pharmacokinetics and biopharmaceuticals, definitions and information related to reference drug and equivalent drug, bioavailability, bioequivalence.
- Learn basic information about the design, evaluation and calculation of pharmacokinetic parameters of bioavailability / bioequivalence studies.
- Learn the information about Biopharmaceutical Classification System (BCS) and biowaiver with examples.
- Learn the concepts and information about pharmacokinetic modeling.
- Have information about legal regulations about bioavailability and bioavailability (TITCK, EMA, FDA, WHO).
- Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
- Provides information and counseling to other healthcare 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 | ECZ428 covers the basic concepts in biopharmaceutical, definition of bioavailability and bioequivalence, the basic concepts in pharmacokinetic, linear and nonlinear pharmacokinetic, legal regulations about bioavailability and bioequivalence. |
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| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Basic concepts in biopharmaceutical, bioavailability and bioequivalence definitions |
|
2nd Week |
Dissolution, solubility, factors affecting solubility and dissolution rate, dissolution rate determination methods and Pharmacopoeia methods |
|
3rd Week |
Comparison of dissolution rate results, model independent methods, model dependent methods |
|
4th Week |
Assesment of in vitro- in vivo (IVIV)corelation |
|
5th Week |
Basic concepts in pharmacokinetics, linear and nonlinear pharmacokinetics |
|
6th Week |
Pharmacokinetic modeling; single compartment model (ıv and ıv infusion), absorption administration, multiple dosing |
|
7th Week |
MID TERM EXAMINATION |
|
8th Week |
Two compartment model: Basic concepts, I.V. injection, I.V. infusion and absorption administration |
|
9th Week |
Design of bioavailability and bioequivalence studies, |
|
10th Week |
Bioavailability / bioequivalence parameters, calculations, assessment of bioavailability / bioequivalence studies, |
|
11th Week |
Factors affecting bioavailability and bioequivalence, |
|
12th Week |
Bioequivalence assessments in different dosage forms (such as imediately release, controlled release and fixed dose combinations) |
|
13th Week |
Bioavailability / bioequivalence assessments in nonlinear drugs and highly variable drugs |
|
14th Week |
Regulations of bioavailability / bioequivalence, biowaiver and biosimilarity, BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system) |
|
| Recommended or Required Reading | 1. Lecture 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.,)
3. Modern Pharmaceutics, Ed: Banker GS, Marcel Dakker Inc. New York, 2008..
4. J.G.Wagner, Fundamentals of Pharmacokinetics, Hamilton Press, Inc., Hamilton, Illinois 62341.
4. Guidelines of Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy,
5. Guidelines of European Medicines Agency (EMA),
6. Guidelines of US Food and Drug Administration (FDA) |
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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 |
2 |
28 |
| Preparation for Final exam |
1 |
12 |
12 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
12 |
12 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
3 |
3 |
| Homework |
1 |
6 |
6 |
| Total Work Load | 91 |
| Total Work Load / 30 (h) | 3.03 |
| ECTS Credit of the Course | 3 |
|
| Language of Instruction | Turkish |
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| Work Placement(s) | No |
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