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Information
| Code | BTE0053 |
| Name | Biosimilar Medicines and Biotechnology |
| Term | 2024-2025 Academic Year |
| Semester | . Semester |
| Duration (T+A) | 3-0 (T-A) (17 Week) |
| ECTS | 6 ECTS |
| National Credit | 3 National Credit |
| Teaching Language | İngilizce |
| Level | Doktora Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Prof. Dr. NACİYE DÖNDAŞ |
Course Goal / Objective
Within the scope of this course, it was aimed to teach definition of biosimilar drugs, differences between biotechnological reference medicine and biosimilar medicine, in vitro and in vivo production methods of biosimilars and recombinant DNA technology, comparison studies of biosimilars with reference biotechnological drugs; safety, efficacy, quality profiles, the effect of atypical glycosylation pattern in biosimilars on pharmacokinetic, pharmacodynamic and immunogenicity parameters, risk factors, pharmacovigilance, isolation and purification techniques of biosimilars, biosimilar product bioanalysis, analytical methods; high-pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDS-PAGE), medical application examples in biosimilar drugs, approval processes and global regulations of biosimilar drugs, and biosimilar drug R&D strategies.
Course Content
Definition of biosimilar drugs, differences between biotechnological reference medicine and biosimilar medicine, in vitro and in vivo production methods of biosimilars and recombinant DNA technology, comparison studies of biosimilars with reference biotechnological drugs; safety, efficacy, quality profiles, the effect of atypical glycosylation pattern in biosimilars on pharmacokinetic, pharmacodynamic and immunogenicity parameters, risk factors, pharmacovigilance, isolation and purification techniques of biosimilars, biosimilar product bioanalysis, analytical methods; high pressure liquid chromatography (HPLC), mass spectrometry (MS), polyacrylamide gel electrophoresis (SDS-PAGE), medical application examples in biosimilars, approval processes and global regulations of biosimilars, biosimilar drug R&D strategies.
Course Precondition
No Prerequisites
Resources
1. Feng X, Xie HG, Malhotra A, Yang CF. Biologics and Biosimilars Drug Discovery and Clinical Applications, CRC Press, 2022 2. Endrenyi L, Chow SC, Paul Declerck P. Biosimilar Drug Product Development, CRC Press, 2017.
Notes
Scientific database
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | The student knows and explains the differences between a biotechnological reference drug and a biosimilar drug. |
| LO02 | Comparison studies of a biosimilar drug with a reference biotechnological drug; Knows and applies methods and techniques |
| LO03 | Knows and explains examples of medical applications in biosimilar drugs |
| LO04 | Know and explain biosimilar drugs approval processes and global regulations, biosimilar drug R&D strategies |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Develop and deepen the current and advanced knowledge in the field with original thought and / or research at the level of expertise based on the qualifications of the graduate and reach the original definitions that will bring innovation to the field. | 3 |
| PLO02 | Bilgi - Kuramsal, Olgusal | Understands the interdisciplinary interaction of the field; it achieves original results using knowledge requiring expertise in analysis, synthesis and evaluation of new and complex ideas. | 3 |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Evaluates, uses and transfers new information in the field with a systematic approach. | 3 |
| PLO04 | Beceriler - Bilişsel, Uygulamalı | Makes critical analysis, synthesis and evaluation of new and complex thoughts. | 3 |
| PLO05 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Makes leadership in environments that require the analysis of original and interdisciplinary problems. | 3 |
| PLO06 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | It extends the limits of knowledge in its field by publishing at least one scientific article in its field in national and / or international refereed journals and / or producing or interpreting an original work. | 4 |
| PLO07 | Yetkinlikler - Öğrenme Yetkinliği | Develops new ideas and methods related to the field by using high level mental processes such as creative and critical thinking, problem solving and decision making. | |
| PLO08 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | He / she defends his / her original opinions in discussing the subjects in his / her field and establishes an effective communication showing his / her competence in the field. | |
| PLO09 | Yetkinlikler - Alana Özgü Yetkinlik | Conducts scientific research in national and international scientific research groups. | 5 |
| PLO10 | Yetkinlikler - Alana Özgü Yetkinlik | Establishes functional interaction by using strategic decision making processes in solving problems encountered in the field. | 3 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Definition of biosimilar drugs, differences between biotechnological reference drug and biosimilar drug | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | In vitro and in vivo production methods of biosimilar drugs and recombinant DNA technology | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Comparison studies of biosimilar drug with reference biotechnological drug; safety, efficacy, quality profiles | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | Effect of atypical glycosylation pattern in biosimilar drugs on pharmacokinetic, pharmacodynamic and immunogenicity parameters | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Risk factors in biosimilar drugs, pharmacovigilance | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | Isolation and purification techniques of biosimilar drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | Biosimilar product bioanalysis | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Analytical methods; Polyacrylamide gel electrophoresis (SDSPAGE) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 9 | high pressure liquid chromatography (HPLC) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Mass spectrometry (MS) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Polyacrylamide gel electrophoresis (SDS-PAGE) | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | Examples of medical applications in biosimilar drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Approval processes and global regulations for biosimilar drugs | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | Biosimilar drug R&D strategies-1 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Biosimilar drug R&D strategies-2 | Books and scientific databases | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Midterm exam | Ölçme Yöntemleri: Yazılı Sınav |
|
| 17 | Semester final exam | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 3 | 42 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 5 | 70 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 15 | 15 |
| Final Exam | 1 | 30 | 30 |
| Total Workload (Hour) | 157 | ||
| Total Workload / 25 (h) | 6,28 | ||
| ECTS | 6 ECTS | ||