TÜRKÇE
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Information
| Unit | FACULTY OF PHARMACY |
| PHARMACY PR. | |
| Code | ECF422 |
| Name | Pharmaceutical Biotechnology |
| Term | 2020-2021 Academic Year |
| Semester | 8. Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 2 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Label | C Compulsory |
| Mode of study | Uzaktan Öğretim |
| Catalog Information Coordinator | Doç. Dr. UMAY MERVE GÜVEN BÖLGEN |
| Course Instructor |
Dr. Öğr. Üyesi ESRA DEMİRTÜRK
(Bahar)
(A Group)
(Ins. in Charge)
Doç. Dr. UMAY MERVE GÜVEN BÖLGEN (Bahar) (A Group) (Asst. Ins.) |
Course Goal / Objective
The aim of this course is to explain the roles, duties and responsibilities of the pharmacist who has knowledge about pharmaceuticals, biological medicinal products and combination products within the scope of pharmaceutical biotechnology, their life cycles in health system including clinical research of these drugs / products.
Course Content
To provide information about biological medicinal products, biosimilar drugs, advanced treatment medicinal products, stem cell-derived drugs, individual medicines, properties, production technologies, quality assurance, comparability studies, licensing with risk-based approach, distribution, follow-up and applications in clinical treatment .
Course Precondition
Resources
Notes
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Explains pharmaceutical biotechnology and research subjects. |
| LO02 | List the uses of recombinant DNA technology. |
| LO03 | Explain gene cloning steps. |
| LO04 | Classifies therapeutic proteins according to their biological function. |
| LO05 | Discusses pharmaceutical forms in a comparative manner. |
| LO06 | Discuss the appropriateness of the routes of administration of pharmaceutical forms depending on the protein properties. |
| LO07 | List the finished product analyzes of the recombinant Therapeutic protein. |
| LO08 | Discuss the finished product stability studies and the methods used. |
| LO09 | Discuss the transfer of the amplified DNA to the vector. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | - | Have sufficient knowledge in pharmaceutical field and develop the knowledge gained. | 3 |
| PLO02 | - | Applies the profession in accordance with the existing laws and regulations,gains awareness of professional and ethical responsibility. | 1 |
| PLO03 | - | It serves the society as a pharmacist who is loyal to Atatürk's principles and reforms, equipped with Universal Knowledge, who uses Turkish correctly and knows at least one foreign language. | 0 |
| PLO04 | - | Communicates effectively both orally and in writing. | 2 |
| PLO05 | - | External appearance, attitude, attitude and behavior, with professional identity, role model and society becomes an example to colleagues. | 2 |
| PLO06 | - | Provides consultancy services to patients, community and health care personnel with a wide range of information on the drug,evaluates advanced knowledge and skills with a critical approach. | 5 |
| PLO07 | - | Possessing the knowledge of historical and current developments in the field of Pharmacy, monitoring, evaluation and application of scientific and evidence-based data, and adopting lifelong learning. | 5 |
| PLO08 | - | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | 3 |
| PLO09 | - | Interprets information about current health and treatment problems. Plays an active role in community health. | 3 |
| PLO10 | - | Pharmacy integrates and develops professional knowledge with information from different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | 3 |
| PLO11 | - | Students will be able to use the concepts and applications of basic sciences and basic medical sciences effectively in the field of Medicine and pharmacy and have the experience of working with these health sciences. | 3 |
| PLO12 | - | Acquires basic information about diseases, adopts and applies rational drug use on all drugs that affect systems. | 2 |
| PLO13 | - | By learning the basics of Clinical Pharmacy,will have the knowledge and skills to help provide drug/patient oriented pharmacy applications and individualized Pharmaceutical Care. | 2 |
| PLO14 | - | It plays a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | 5 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Introduction to molecular biotechnology and pharmaceutical biotechnology | Observation-Research | |
| 2 | Hybridoma technology, monoclonal antibodies, properties and analysis | Observation-Research | |
| 3 | Physicochemical properties, stability and analysis methods of peptides and proteins | Observation-Research | |
| 4 | Vaccines (recombinant and DNA vaccines) vaccine adjuvants, properties and analyzes | Observation-Research | |
| 5 | Preformulation and formulation in recombinant protein drugs | Observation-Research | |
| 6 | Preformulation, formulation, pharmacopeia analysis and quality controls in recombinant protein drugs | Observation-Research | |
| 7 | Biosimilar drugs | Observation-Research | |
| 8 | Mid-Term Exam | exam | |
| 9 | Advanced treatments, advanced treatment medical products, combined advanced treatment medical products | Observation-Research | |
| 10 | Stem cell technologies, stem cell-derived medical products | Observation-Research | |
| 11 | Gene technologies, gene transfer methods | Observation-Research | |
| 12 | pharmacogenomics | Observation-Research | |
| 13 | clinical research and regenerative medical studies | Observation-Research | |
| 14 | analyzes in recombinant proteins | Observation-Research | |
| 15 | pharmacopoeia analysis and quality controls | Observation-Research | |
| 16 | Term Exams | exam | |
| 17 | Term Exams | exam |
Assessment (Exam) Methods and Criteria
| Assessment Type | Midterm / Year Impact | End of Term / End of Year Impact |
|---|---|---|
| 1. Midterm Exam | 100 | 40 |
| General Assessment | ||
| Midterm / Year Total | 100 | 40 |
| 1. Final Exam | - | 60 |
| Grand Total | - | 100 |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 4 | 4 |
| Final Exam | 1 | 8 | 8 |
| Total Workload (Hour) | 54 | ||
| Total Workload / 25 (h) | 2,16 | ||
| ECTS | 2 ECTS | ||