GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PHARMACEUTICAL PRODUCTION PROCESSES AND TECHNOLOGIES/EE-1110
Course Title: PHARMACEUTICAL PRODUCTION PROCESSES AND TECHNOLOGIES
Credits 3 ECTS 7
Semester 1 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Füsun Acartürk, Prof. Sevgi Takka, Assoc.Prof. Dr. Zeynep Şafak Teksin
 -- WEB SITE(S) OF LECTURER(S)
  http://www.websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/takka, http://www.websitem.gazi.edu.tr/site/zsteksin
 -- EMAIL(S) OF LECTURER(S)
  acarturk@gazi.edu.tr, takka@gazi.edu.tr, zsteksin@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learning the basic concepts and knowldege for developing of pharmaceutical products, parameters effecting formulations
Learning the development of new drug forms and generic drug formulations
Learning the concepts of dimensional analysis and scale up in industry
Learning scale-up processes for different drug forms
 -- 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 importance and necessity of R & D studies in drug development
2. Week   Candidate drug selection and drug development
3. Week  Development of new drug and generic formulations
4. Week  Importance of impurities in drug development
5. Week  Cell culture studies in drug development
6. Week  Pharmaceutical development in silico models
7. Week  Technology transfer
8. Week  Pharmaceutical scale up process for developing a new drug design and generic formulation.
9. Week  Industrial application and dimentional analysis in theory and scale up
10. Week   Scale up on parenteral drugs
11. Week   Scale up on liquid and semi-solids
12. Week  Scale up on granulation and drying process
13. Week   Scale up on solid dosage forms
14. Week  Scale up on film coating
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  Modern Pharmaceutical Technology,Encyclopedia of Pharmaceutical Technology
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Drill - Practise
 -- WORK PLACEMENT(S)
  -
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
1
5
 Assignment
1
40
 Exercises
0
0
 Projects
1
20
 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
0
0
 Reading
10
5
50
 Searching in Internet and Library
8
4
32
 Designing and Applying Materials
4
1
4
 Preparing Reports
6
3
18
 Preparing Presentation
4
4
16
 Presentation
4
3
12
 Mid-Term and Studying for Mid-Term
1
6
6
 Final and Studying for Final
1
9
9
 Other
0
0
0
 TOTAL WORKLOAD: 
175
 TOTAL WORKLOAD / 25: 
7
 ECTS: 
7
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Follow the development as having the knowledge and skills in the field of industrial pharmacy, transfer the information to the pharmaceutical industry and develop new approaches in this area.X
2Gains the ability to acess and apply to the health orginazations guidlines such as FDA, EMA, WHO.X
3Preparation and evaluation of the CTD format of the license application to the Turkish Drug and Medical Devices Agency and learn the types of license application made to the other health organizationsX
4Posess the knowledge on the total quality management, GMP, GLP, GSP, QA / QC, process validation, analytical validation and qualification in in the pharmaceutical industry.X
5Learns the concept of systematic R&D, techniques, tools and scale up in drug development.X
6Learns the concept and application of drug formulation development by using quality by design (QbD) and process analytical technology (PAT).X
7Posseses the ability to evaluate and interprete the drug patent databases (TPE, EPO, WIPO etc.)X
8Learns the concept of original and generic drug and the evaluation and interpretation of the study design of bioavalability/bioequivalanceX
9Posess the knowledge and skill about the analytical techniques, method development and validation in the industrial pharmacy.X
10Get the application skill in the releated area by pursuing knowledge in the field of pharmacovigilance and pharmacoeconomics.
11Develops new approaches to potential problems and bring solutions by using the knowledge in the releated area.X