EAG606 - TOXICOLOGY and TOXICOLOGICAL ANALYSES
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| TOXICOLOGY and TOXICOLOGICAL ANALYSES | EAG606 | 2nd Semester | 2 | 0 | 2 | 4 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Must | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion | |||||
| Instructor (s) | Prof. Dr. ÜLFET PINAR ERKEKOGLU, Prof. Dr. TERKEN BAYDAR,Prof. Dr. SUNA SABUNCUOGLU,Doç. Dr. GÖZDE GIRGIN,Prof. Dr. SEVTAP AYDIN DILSIZ,Prof. Dr. ÜLKÜ ÜNDEGER BUCURGAT,Prof. Dr. AYLIN GÜRBAY | |||||
| Course objective | This course aims to inform students about the basic concepts of Toxicology and basic toxicity tests used in preclinical AR-GE studies | |||||
| Learning outcomes |
| |||||
| Course Content | General concepts of toxicology, classification of toxic effect, toxicokinetics, mechanisms of toxic effect, special toxic effect, toxicity tests, Toxicological Analyses and assessments | |||||
| References | Cassarett and Doull's Toxicology, OECD guidelines, ICH guidelines | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Introduction to Toxicology, Definitions, General Concepts |
| Week 2 | Toxicokinetics |
| Week 3 | Toxic Effect Classifications, Factors Affecting Toxicity, Toxicity Mechanisms |
| Week 4 | Special Toxic Effects: Genotoxicity, Teratogenicity, Carcinogenicity |
| Week 5 | Dose-Response Relationships General Toxicity Tests in OECD and ICH Guidelines: Acute Toxicity Tests |
| Week 6 | General Toxicity Tests in OECD and ICH Guidelines: Subacute, Subchronic and Chronic Toxicity Tests |
| Week 7 | Special Toxicity Tests in OECD and ICH Guidelines: Reproductive Toxicity Tests, Developmental Toxicity Tests, Immunotoxicity Tests |
| Week 8 | Special Toxicity Tests in OECD and ICH Guidelines: Carcinogenicity Tests, Mutagenicity Tests, Teratogenicity Tests |
| Week 9 | 3R Principle and Alternative Toxicity Tests |
| Week 10 | Cell and Tissue Cultures in Toxicology |
| Week 11 | Skin and Eye Irritation Tests, Skin Sensitivity Tests, Phototoxicity Tests |
| Week 12 | Toxicological Evaluation of Nanomaterials |
| Week 13 | Toxicological Evaluation of Biotechnological Products |
| Week 14 | Toxic Substance Directives of European Union, Classification, Packaging and Labeling of Toxic Substances according to European Union (REACH) |
| Week 15 | Compensation |
| Week 16 | Final exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 1 | 10 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 0 | 0 |
| Final exam | 1 | 90 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 10 |
| Percentage of final exam contributing grade succes | 1 | 90 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 2 | 28 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 4 | 56 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 1 | 11 | 11 |
| Midterms (Study duration) | 0 | 0 | 0 |
| Final Exam (Study duration) | 1 | 25 | 25 |
| Total Workload | 30 | 42 | 120 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has knowledge in the area of preformulation and formulation designs about industrial production, quality control, quality assurance system and stability | |||||
| 2. Acquires information about nanotechnology, new drug delivery systems and controlled release systems | |||||
| 3. Learns to keep track of up to date literature and patents using the knowledge and informatics technologies | X | ||||
| 4. Interprets the guidelines of health authorities such as FDA, EMA and international guidelines such as GMP, ANDA, BA/BE, QA/QC, acquires application knowledge and skills | X | ||||
| 5. Has knowledge to understand and interpret chemical, instrumental and pharmacological data | X | ||||
| 6. Has basic concepts about medicinal chemistry such as design of new drug molecules, drug-receptor interactions | |||||
| 7. Has the knowledge on the rules of scientific ethics which should be complied | X | ||||
| 8. Effectively uses the conventional and new synthetic methods. | |||||
| 9. Has knowledge of advanced toxicity tests accepted by regulatory authorities | X | ||||
| 10. Has knowledge about pharmacological experimental methods and their applications used in drug research and evaluates analysis results | X | ||||
| 11. Has knowledge about preclinical and clinical drug research | X | ||||
| 12. Has knowledge about the pharmacokinetic and pharmacodynamic properties of drugs | X | ||||
| 13. Has knowledge about the pharmacokinetics and pharmacodynamics of drugs | |||||
| 14. Has knowledge of and the ability to use the devices and instruments used in the application of instrumental analysis methods | |||||
| 15. Has the ability to apply theoretical and practical knowledge in the analysis of substances in medicinal products and biological materials | |||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest