Information Package / Course Catalogue
Biopharmaceuticals
Course Code: MBTK540
Course Type: Area Elective
Couse Group: Second Cycle (Master's Degree)
Education Language: Turkish
Work Placement: N/A
Theory: 3
Prt.: 0
Credit: 3
Lab: 0
ECTS: 8
Objectives of the Course

The aim of this course is to give ability to provide knowledge and skills about biopharmaceuticals

Course Content

Biopharmaceutical classification, bioavailability criteria, bioequivalence criteria, FDA and EMA guidelines will be explained.

Name of Lecturer(s)
Prof. Özge ÇEVİK
Learning Outcomes
1.1. Will have knowledge about biopharmaceuticals
2.Will know and use the methods used for the production of biopharmaceuticals
3.Will know and practice the guidelines in biopharmaceuticals
4.Will recognition and application of biopharmaceutical products
5.Will having knowledge about production policies of biopharmaceutical products
Recommended or Required Reading
1.All scientific journals and textbook on recombinant proteins
Weekly Detailed Course Contents
Week 1 - Theoretical
Introduction to Biopharmaceuticals
Week 2 - Theoretical
Biosensors and classification
Week 3 - Theoretical
Development stages of biosensors
Week 4 - Theoretical
Drug dissolution
Week 5 - Theoretical
Drug absorption and absorption mechanisms
Week 6 - Theoretical
Bioavailability
Week 7 - Theoretical
Bioequivalence-I
Week 8 - Theoretical
Bioequivalence-II (Midterm exam)
Week 9 - Theoretical
In vivo determination of bioavailability and bioequivalence
Week 10 - Theoretical
In vitro-in vivo correlation
Week 11 - Theoretical
FDA guidelines
Week 12 - Theoretical
EMA guidelines
Week 13 - Theoretical
Production of biosimilar products in Turkey
Week 14 - Theoretical
Production policies of biodegradable products in the world
Assessment Methods and Criteria
Type of AssessmentCountPercent
Midterm Examination1%30
Final Examination1%70
Workload Calculation
ActivitiesCountPreparationTimeTotal Work Load (hours)
Lecture - Theory140342
Assignment501575
Term Project2048
Individual Work130565
Midterm Examination1033
Final Examination1033
TOTAL WORKLOAD (hours)196
Contribution of Learning Outcomes to Programme Outcomes
PÇ-1
PÇ-2
PÇ-3
PÇ-4
PÇ-5
PÇ-6
PÇ-7
PÇ-8
PÇ-9
PÇ-10
PÇ-11
PÇ-12
PÇ-13
OÇ-1
5
5
5
5
5
5
5
5
5
5
5
5
5
OÇ-2
5
5
5
5
5
5
5
5
5
5
5
5
5
OÇ-3
3
3
3
3
3
3
3
3
3
3
3
3
3
OÇ-4
5
5
4
4
4
4
4
4
4
4
4
4
4
OÇ-5
5
5
4
5
4
4
4
4
4
4
4
4
4
Adnan Menderes University - Information Package / Course Catalogue
2026