GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PHARMACEUTICAL BIOTECHNOLOGY II. MONOCLONAL DRUG MANUFACTURING TECHNOLOGY/FTE-2140
Course Title: PHARMACEUTICAL BIOTECHNOLOGY II. MONOCLONAL DRUG MANUFACTURING TECHNOLOGY
Credits 2 ECTS 7
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof.Füsun Acartürk, Assoc.Prof. Sibel İlbasmış Tamer
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/ilbasmis
 -- EMAIL(S) OF LECTURER(S)
  acarturk@gazi.edu.tr, ilbasmis@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
The monoclonal antibodies used in cancer treatment and diagnosis with the learning basic concepts and recent developments
Monoclonal antibodies to know the difference from other conventional drugs
Understanding of the importance of new drug delivery systems to treat cancer
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 -- MODE OF DELIVERY
  The mode of delivery of this course is Face to face
 -- PREREQUISITES AND CO-REQUISITES
  There is no prerequisite or co-requisite for this course.
 -- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS
  There is no recommended optional programme component for this course.
 --COURSE CONTENT
1. Week  The production of monoclonal antibodies
2. Week  The production of monoclonal antibodies
3. Week  The scale-up of monoclonal antibodies
4. Week  The scale-up of monoclonal antibodies
5. Week  Purification of monoclonal antibodies
6. Week  The usage as therapeutic agents and drug delivery systems
7. Week  The usage as therapeutic agents and drug delivery systems
8. Week  PK/PD in clinical development of monoklonal antibody therapeutics
9. Week  The pharmacokinetics of monoklonal antibodies and case studies
10. Week  The preparation of immunoconjugate and radioimmunoconjugate from monoclonal antibodies
11. Week  The preparation of immunoconjugate and radioimmunoconjugate from monoclonal antibodies
12. Week  The problems and solutions in formulation of monoklonal antibodies
13. Week  Targetting monoclonal antibodies and the usage in therapy
14. Week  Targetting monoclonal antibodies and the usage in therapy.
15. Week  -
16. Week  -
 -- RECOMMENDED OR REQUIRED READING
  -Protein Delivery, Ed: L.M.Sanders and R.W. Hendren,1997, New York. -Pharmaceutical Technology, Ed: D.J.A. Crommelin, R.D. Sindelar, 1997, Netherland
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  NA
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
0
0
 Assignment
1
10
 Exercises
0
0
 Projects
1
30
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
40
 Contribution of Final Examination to Overall Grade  
60
 -- WORKLOAD
 Efficiency  Total Week Count  Weekly Duration (in hour)  Total Workload in Semester
 Theoretical Study Hours of Course Per Week
14
2
28
 Practising Hours of Course Per Week
0
 Reading
10
4
40
 Searching in Internet and Library
10
3
30
 Designing and Applying Materials
0
 Preparing Reports
7
4
28
 Preparing Presentation
6
4
24
 Presentation
4
2
8
 Mid-Term and Studying for Mid-Term
1
7
7
 Final and Studying for Final
1
10
10
 Other
0
 TOTAL WORKLOAD: 
175
 TOTAL WORKLOAD / 25: 
7
 ECTS: 
7
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Posesses extensive knowledge accumulation on the field of Pharmaceutical Technology, learns pre-formulations of all pharmaceutical dosage forms, formulation designs and in vitro/in vivo evaluations of formulations.X
2Gains the capability of following up novalities in technology, and posesses the capability of literature search, evaluation and interpretation on the fields of Pharmacy.X
3Gains the capability of patent search and evaluation and patenting regarding the formulations of active drug ingredient, dosage forms and preparation technologies.X
4Learns sufficient knowledge on the the field of laboratory, pilot batch and industrial scale productions, quality controls, quality assurance system, good manufacture practice (GMP) and stability assurance of all dosage forms.X
5Learns the knowledge satisfying the capability level for designing original and generic drugs, evaluating process validation and quality assurance.X
6Learns the interpretation, statistical evaluation and practical application of the research results.X
7Posesses the knowledge on new drug delivery systems and posesses the knowledge and capacity on targetting these systems at a level of an expert.X
8Learns designing, formulations, preparation techniques, physical and chemical stabilities of biotechnological products.X
9Gains the capability of finding solutions to the problems encountered during research. He/she gains the capability of analytical thinking. He/she gains the capability of publishing the experimental results in the national/international journals.X
10Gains the capability of following and interpretion of important wold health organizations (FDA, EMA, ICH and WHO) and official reference books (pharmacopoeia etc.). As a result, he/she transfers his/her knowledge to the field of Pharmaceutical Technology, and develops new approaches.X