GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
QUALITY CONTROL AND INSTRUMENTAL ANALYSIS METHODS IN PHARMACY/EE-1090
Course Title: QUALITY CONTROL AND INSTRUMENTAL ANALYSIS METHODS IN PHARMACY
Credits 2 ECTS 7
Semester 2 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof. Nusret Ertaş
 -- WEB SITE(S) OF LECTURER(S)
  http://www.websitem.gazi.edu.tr/site/nertas
 -- EMAIL(S) OF LECTURER(S)
  nertas@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Conventional and on-line Analytical techniques used for quality control during the process will be discussed.
Analytical methods that are used for drug determination in biological samples will be discussed.
Topics will be discussed comparatively in terms of validation parameters.
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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  Analytical Techniques for quality control, measurements on process and end products: UV-VIS, Fluorescence Spectrometer
2. Week  On-line process and quality control, Near-IR
3. Week  Chromatography, HPLC, UPLC-(UV, DAD, Fluorescence), GC
4. Week  Chromatography, HPLC, UPLC-(UV, DAD, Fluorescence), GC
5. Week  Chromatography, HPLC, UPLC-(UV, DAD, Fluorescence), GC
6. Week  Evaluation of the Analytical techniques in terms of validation parameters
7. Week  Drug determination in biological samples. Sample preparation methods: Solid phase extraction, liquid-liquid extraction, derivatisation
8. Week  Methods for the construction of calibration plot: direct calibration, use of internal standard,quality control samples. Effect of interferences
9. Week  Instruments with mass spectrometry (TOF, Quadrupole-MS) GS-MS, LC-MS, LC MS/MS
10. Week  GS-MS, LC-MS, LC MS/MS
11. Week  GS-MS, LC-MS, LC MS/MS
12. Week  GS-MS, LC-MS, LC MS/MS
13. Week  Evaluation of the Analytical techniques in terms of validation parameters
14. Week  The criteria of method selection for Bioavailability and Bioequivalence studies and related problems
15. Week  -
16. Week  -
 -- RECOMMENDED OR REQUIRED READING
  Analytical Chemistry books
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture, Question & Answer, Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  NA
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
1
30
 Assignment
1
30
 Exercises
0
0
 Projects
0
0
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
60
 Contribution of Final Examination to Overall Grade  
40
 -- 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
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.X
11Develops new approaches to potential problems and bring solutions by using the knowledge in the releated area.X