At the end of this course, the students; 1) Learn concepts of natural, synthetic, and semi-synthetic bioactive compounds, principles of extracting natural bioactive compounds, and biotechnology approaches in bioactive compound modification. 2) Understand basic strategies in development of targeted new molecules with known indications, biosimilar concept, good laboratory and manufacture practices. 3) Recognize strategies and applications from research and development phase to an authorized drug formulation.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
No
COURSE DEFINITION
COURSE CONTENTS
WEEK
TOPICS
1st Week
1. Introduction and Basic Concepts
2nd Week
2. concepts of natural, synthetic, and semi-synthetic bioactive compounds
3rd Week
3. principles of extracting natural bioactive compounds
4th Week
4. biotechnology approaches in bioactive compound modification Pharmaceutical Applications
5th Week
5. basic strategies in development of targeted new molecules with known indications
6th Week
6. Literature discussions
7th Week
7. biosimilar concept
8th Week
8. MIDTERM
9th Week
9. Drug Formulations
10th Week
10. GLP and GMP Concepts
11th Week
11. Phase Studies
12th Week
12. Patent Issues
13th Week
13. Recognition of Developed Drugs by Health Authorities
14th Week
14. Student presentations
15th Week
RECOMENDED OR REQUIRED READING
? Güncel literatür. / Update literature covering the studies in the area. ? Molecular Biotechnology, Principles and Applications of Recombinant DNA. Bernard R. Glick, Jack J. Pasternak, ASM Press, Washington, D.C., 2009.
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Lecture,Discussion,Questions/Answers,Presentation
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Mid-term
1
35
Assignment
1
20
Total(%)
55
Contribution of In-term Studies to Overall Grade(%)
55
Contribution of Final Examination to Overall Grade(%)
45
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
1
84
84
Preparation for Quiz
1
16
16
Individual or group work
0
0
0
Preparation for Final exam
1
24
24
Course hours
14
3
42
Preparation for Midterm exam
1
11
11
Laboratory (including preparation)
0
0
0
Final exam
1
96
96
Homework
1
12
12
Project
1
12
12
Total Workload
297
Total Workload / 30
9,9
ECTS Credits of the Course
10
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)