| Course Unit Title | Course Unit Code | Type of Course Unit | Level of Course Unit | Year of Study | Semester | ECTS Credits |
|---|---|---|---|---|---|---|
| Biosimilar Drugs | FRM705 | Elective | Doctorate degree | 1 | Spring | 3 |
Name of Lecturer(s)
Prof. Dr. Semil Selcen GÖÇMEZ
Learning Outcomes of the Course Unit
1) At the end of this course, the students will be able to;
Categorize peptids and proteins that are biotechnological products.
Define the recombinant biopharmaceutics, tell the preparation of recombinant biopharmaceutics.
Define biosimilar drugs, tell the speciality of biosimilar drugs, summarize the application of cell culture.
Explain the licensing and patent requirement of biosimilar drugs.
Explain new development in biotechnological products and it’s safety and ethical issues.
Program Competencies-Learning Outcomes Relation
| Program Competencies | |||||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | ||
| Learning Outcomes | |||||||||||||
| 1 | No relation | No relation | No relation | No relation | No relation | No relation | No relation | High | High | High | High | High | |
Mode of Delivery
Face to Face
Prerequisites and Co-Requisites
None
Recommended Optional Programme Components
Physiology
Course Contents
Recombinant DNA technology, Fermentation Technology Pharmaceutical biotechnology-derived biological drugs, processes of licensing, pharmacovigilance, biovigilance Pharmaceutical biotechnology-derived biological drugs, processes of licensing, pharmacovigilance, biovigilance Recombinant Biopharmaceuticals I: monoclonal antibodies, vaccine delivery systems and adjuvants, cytokines), Cell Culture Recombinant Biopharmaceuticals I: monoclonal antibodies, vaccine delivery systems and adjuvants, cytokines), Cell Culture .Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-relateddrugs and erythropoietin Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin Mid-term exam Herbal Biopharmaceuticals Biosimilar drugs Biosimilar drugs Biosimilar drugs Innovative drugs in pharmaceutical biotechnology Ethic, safety, licensing and patents in biotechnological products Ethic, safety, licensing and patents in biotechnological products Final Exam
Weekly Schedule
1) Recombinant DNA technology, Fermentation Technology2) Pharmaceutical biotechnology-derived biological drugs, processes of licensing, pharmacovigilance, biovigilance
3) Pharmaceutical biotechnology-derived biological drugs, processes of licensing, pharmacovigilance, biovigilance
4) Recombinant Biopharmaceuticals I: monoclonal antibodies, vaccine delivery systems and adjuvants, cytokines), Cell Culture
5) Recombinant Biopharmaceuticals I: monoclonal antibodies, vaccine delivery systems and adjuvants, cytokines), Cell Culture
6) Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-relateddrugs and erythropoietin
7) Recombinant Biopharmaceuticals II: insulin, therapeutic hormones, therapeutic enzymes and clotting-related drugs and erythropoietin
8) Mid-term exam
9) Herbal Biopharmaceuticals
10) Biosimilar drugs
11) Biosimilar drugs
12) Biosimilar drugs
13) Innovative drugs in pharmaceutical biotechnology
14) Ethic, safety, licensing and patents in biotechnological products
15) Ethic, safety, licensing and patents in biotechnological products
16) Final Exam
Recommended or Required Reading
1- Crommelin DJA, Sindelar RD, Meibohm B. Pharmaceutical Biotechnology Fundamentals and Applications. 5th Ed. Springer (ISBN 978-3-030-00710-2 (eBook))
Planned Learning Activities and Teaching Methods
1) Lecture
2) Question-Answer
3) Discussion
4) Group Study
5) Self Study
Assessment Methods and Criteria
Contribution of Midterm Examination to Course Grade |
30% |
|---|---|
Contribution of Final Examination to Course Grade |
70% |
Total |
100% |
Language of Instruction
Turkish
Work Placement(s)
Not Required