Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
300005492015BIYOSIMILAR DRUGSElective593
Level of Course Unit
First Cycle and Second Cycle
Language of Instruction
Objectives of the Course
Learning the definition, analyses and approval of biosimilar products
Name of Lecturer(s)
Prof. Dr. Gülten KANTARCI, Dr. Öğretim Üyesi Yücel BAŞPINAR
Learning Outcomes
1Definition of biosimilars and differences to small drug molecules
2Production steps of biosimilars
3Purification of biosimilars
4Formulation aspects o f biosimilars
5Acceptance criteria, quality control and regulatory affairs of biosimilars
Mode of Delivery
Face to Face
Prerequisites and co-requisities
None
Recommended Optional Programme Components
None
Course Contents
Definition, analyses and approval of biosimilar products
Weekly Detailed Course Contents
WeekTheoreticalPracticeLaboratory
1Introduction to biosimilars and definition of them Lecture
2Production of Biosimilars and in process testsLecture
3Purification process of biosimilars Lecture
4Quality control methods of biosimilars Lecture
5Acceptance criteria of biosimilars Lecture
6Comparison of biosimilars and small molecules Lecture
7Discussion with research papers about the subjects above Lecture - Discussion
8Midterm exam
9Biosimilars in Turkey Lecture
10Biosimilars in the World Lecture
11Pre-Clinical and clinical trials of biosimilars Lecture
12Requirements for the approval of biosimilars Lecture
13Interchangeability, switching and substitution of biosimilars Lecture
14Discussion with research papers about the subjects above Lecture - Discussion
15Discussion with research papers about the subjects above Lecture - Discussion
16Final exam
Recommended or Required Reading
1. Glick B.R., Pasternak J.J., Molecular Biotechnology Principles and Applications, 1994. 2. Walsh Gary, Pharmaceutical Biotechnology, Concepts and Applications, 2007.
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
Term (or Year) Learning ActivitiesQuantityWeight
SUM0
End Of Term (or Year) Learning ActivitiesQuantityWeight
SUM0
SUM0
Work Placement(s)
None
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination111
Final Examination111
Attending Lectures14228
Self Study8216
Individual Study for Mid term Examination155
Individual Study for Final Examination11010
Reading14228
TOTAL WORKLOAD (hours)89
Contribution of Learning Outcomes to Programme Outcomes
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LO1232155455553435543335
LO2132155553555324432233
LO3132144554543324432233
LO4132145353555435543334
LO5232155355555435543335
* Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High
 
Ege University, Bornova - İzmir / TURKEY • Phone: +90 232 311 10 10 • e-mail: intrec@mail.ege.edu.tr