GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
DRUG ANALYSIS/FKİ-2080
Course Title: DRUG ANALYSIS
Credits 2 ECTS 6
Course Semester 1 Type of The Course Elective
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish Türkçe
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
Learns drug active ingredient and finished product.
Learns the concept of drug active substance and finished product impurities.
Have knowledge about pharmacopoeia analysis and ICH guideline.
Have knowledge about Drug Master File (DMF)
Learn the active substance analysis methods
Learns method validation and validation parameters
 -- MODE OF DELIVERY
  The mode of delivery of this course is Face to face
 --WEEKLY SCHEDULE
1. Week  The importance of quality control in the pharmaceutical industry, the pharmaceutical industry in Turkey (in terms of production and quality control)
2. Week  Quality control at the place where the drug is produced;
3. Week  Quality control at the place where the drug is produced; Final product analysis.
4. Week  Chemical control of drugs: Quantitative analysis of drug active substances and impurities and analytical methods applied
5. Week  Volumetric and gravimetric methods   Chromatographic methods
6. Week  Gas-Liquid Chromatography Spectrophotometric methods
7. Week  High-pressure liquid chromatography, ultra performance liquid chromatography
8. Week  Definition and rules of method validation
9. Week  Key Parameters and acceptance criteria
10. Week  Reference Standards
11. Week  Validation Strategy and Determination of Validation Parameters
12. Week  Validation Parameters; Selectivity, Specificity, Accuracy, Linearity, Recovery, Accuracy
13. Week  Validation Parameters;Robustness,LoD, LoQ, Matrix Effect
14. Week  Method Validation Application in Drug Analysis
15. Week  
16. Week  
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
60
 Assignment
1
40
 Application
0
0
 Projects
0
0
 Practice
0
0
 Quiz
0
0
 Percent of In-term Studies  
50
 Percentage of Final Exam to Total Score  
50
 -- WORKLOAD
 Activity  Total Number of Weeks  Duration (weekly hour)  Total Period Work Load
 Weekly Theoretical Course Hours
14
2
28
 Weekly Tutorial Hours
0
 Reading Tasks
11
3
33
 Searching in Internet and Library
14
2
28
 Material Design and Implementation
0
 Report Preparing
7
2
14
 Preparing a Presentation
3
4
12
 Presentation
1
2
2
 Midterm Exam and Preperation for Midterm Exam
5
3
15
 Final Exam and Preperation for Final Exam
3
5
15
 Other (should be emphasized)
0
 TOTAL WORKLOAD: 
147
 TOTAL WORKLOAD / 25: 
5.88
 Course Credit (ECTS): 
6
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Applies current knowledge in the field of Pharmaceutical Chemistry with the related field.X
2Comprehends the interdisciplinary interaction related to the field of Pharmaceutical Chemistry and interprets the information to integrate and create new information.X
3Reaches the information about the research topic from national and international resources, compiles and interprets them.X
4Prepares scientific reports of his/her research activities.X
5Uses laboratory equipment including computer which is required during experimental research.X
6Presents the results of the work at national or international meetings organized in the field of expertise.X
7Knows the importance of ethical principles and ethical rules for individual and society, behaves ethically.X
8Applies advanced organic chemistry knowledge and chemical synthesis procedures.
9Performs experiments using separation and purification methods.X
10Elucidates molecular structures using spectral analysis.X
11Evaluates the behavior of the drug in biological systems and proposes a new chemical molecule for drug design.
12Has the knowledge about qualitative and quantitative analysis methods of drugs and applies them.X
13Knows advanced organic chemistry, behavior of drugs in biological systems, qualitative-quantitative and spectral structure analysis methods of drugs, including separation and purification methods.X
 -- NAME OF LECTURER(S)
   (Assoc.Prof. Murat Kadir ŞÜKÜROĞLU)
 -- WEB SITE(S) OF LECTURER(S)
   (www.websitem.gazi.edu.tr/site/mkadir)
 -- EMAIL(S) OF LECTURER(S)
   (mkadir@gazi.edu.tr)