GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
CELL CULTURE IN DRUG DEVELOPMENT AND EVALUATION/FTE-2090
Course Title: CELL CULTURE IN DRUG DEVELOPMENT AND EVALUATION
Credits 2 ECTS 7
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Assoc.Prof.Zeynep Şafak Teksin, Assoc.Prof.Tuba İnceçayır
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/zsteksin, http://websitem.gazi.edu.tr/site/tincecayır
 -- EMAIL(S) OF LECTURER(S)
  zsteksin@gazi.edu.tr, tincecayır@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Understanding of the fundamentals and basic concepts of drug transport and cell culture method.
Understanding of using cell culture methods in pharmaceutical and medical sciences.
The original, generic new drug design, validation of the process of this evaluation, quality assurance that can provide knowledge.
Taking into consideration the interests of the country with his information in the field of health strategies and policies contribute to the planning.
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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  Introduction, basic concepts and the definitions, advantages and disadvantages of cell culture methods, primary and secondary cell cultures, material
2. Week  Preparation of cell cultures, passage, viability and cytotoxicity
3. Week  Using of cell culture methods in pharmaceutical and medical sciences
4. Week  Biological barriers and drug transport routes
5. Week  Cell culture models
6. Week  Importance of Parallel Artificial Membrane Permeability Assay (PAMPA) in drug transport
7. Week  Properties of Caco-2 cell (colon carcinoma cell line) and its importance of drug transport
8. Week  MDCK (Madine-darby canine kidney) cells, pulmoner and epidermal cell culture, theirs properties and importance of drug transport
9. Week  Importance of cell culture in Biopharmaceutics Classification System (BCS)
10. Week  Examples of cell culture in Biopharmaceutics Classification System (BCS)
11. Week  Investigation of enhancement of solubility and permeability in drug formulations with cell culture methods
12. Week  Investigation of enhancement of solubility and permeability in drug formulations with cell culture methods and examples
13. Week  In vitro/in vivo correlation studies using cell culture methods
14. Week  Importance of cell culture methods in determinations of biowaviers and evaluation of different drugs
15. Week  -
16. Week  -
 -- RECOMMENDED OR REQUIRED READING
  -Transport Processes in Pharmaceutical Systems (Drugs and the Pharmaceutical Sciences) Gordon L. Amidon, Ping Lee, and Elizabet Topp, Marcel Dekker, N
 -- 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
12
3
36
 Searching in Internet and Library
14
2
28
 Designing and Applying Materials
0
 Preparing Reports
10
3
30
 Preparing Presentation
8
2
16
 Presentation
1
1
1
 Mid-Term and Studying for Mid-Term
4
3
12
 Final and Studying for Final
6
4
24
 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