GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
ANALYSIS METHODS OF DRUG ACTIVE SUBSTANCES BASED ON INTERNATIONAL GUIDELINES/ECZ 5779
Course Title: ANALYSIS METHODS OF DRUG ACTIVE SUBSTANCES BASED ON INTERNATIONAL GUIDELINES
Credits 2 ECTS 4
Course Semester 9 Type of The Course Elective
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
Knowing active pharmaceutical compound (active substance) concept.
To obtain research ability in national and international pharmacopoeias.
To gain general knowledge about spectral analysis methods.
To gain knowledge about some chromatographic methods and validations.
Learning the concept of impurity in drug, determination of boundaries, analysis and method validations
To gain information about ICH guidelines and use.
Learning of the concept of residue solvent, its analysis and limits.
 -- MODE OF DELIVERY
  The mode of delivery of this course is Face to face
 --WEEKLY SCHEDULE
1. Week  Giving general information about the course objectives and course topics. General information about pharmacopoeia and introduction of used pharmacopoeias
2. Week  Discussion of the concept of drug substance. Explanation of the Active Substance Main File and related sections.
3. Week  General information about elemental analysis, Mass, Nuclear Magnetic Resonance (NMR) and Infared spectroscopy and sample solutions.
4. Week  Drug substance structure characterization. (Illumination of chemical structure, determination of impurities to be formed during synthesis)
5. Week  General information on chromatography and high pressure liquid chromatography (HPLC), determination of the amount of active substance. Method development validation and examination of parameters used in validation and examples.
6. Week  Introducing the ICH guideline
7. Week  Examining the objectives, objectives and general principles of the ICH guideline, Midterm Exam
8. Week  Discussion of the concept of impurity, methods used in the analysis of the impurities, types and impurities that occur in the synthesis of drug substance.
9. Week  Determination of impurity limits and methods used here. Important points in the determination of the parameters to be selected in the method validation of impurity determination. Using the pharmacopoeia and the ICH guideline to determine the limits of impurity.
10. Week  Determination of specifications in the analysis of active substances, establishment of serial analyzes and analysis certificates.
11. Week  Residual solvent result from active substance synthesis. Methods used for this purpose and method validation. Residue solvent limits and their classification according to ICH guidelines.
12. Week  Use of pharmacopoeial and ICH guidelines for drug substance stability tests, purpose and general principles of the stability tests
13. Week  Discussion of samples solutions
14. Week  Homework and discussion
15. Week  
16. Week  
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
70
 Assignment
1
30
 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
3
42
 Weekly Tutorial Hours
0
0
0
 Reading Tasks
6
2
12
 Searching in Internet and Library
3
4
12
 Material Design and Implementation
0
0
0
 Report Preparing
1
6
6
 Preparing a Presentation
1
5
5
 Presentation
1
5
5
 Midterm Exam and Preperation for Midterm Exam
1
6
6
 Final Exam and Preperation for Final Exam
2
6
12
 Other (should be emphasized)
0
 TOTAL WORKLOAD: 
100
 TOTAL WORKLOAD / 25: 
4
 Course Credit (ECTS): 
4
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Completing Bachelor Degree in Pharmacy, the Bachelor of Science graduate is able to apply his/her gained knowledge and skills to all of the fields of Pharmacy profession within the framework of law, regulations, principles, professional values and ethical rules.X
2Combining with the applications regarding Pharmacy profession, he/she is able to use the concepts and applications of fundamental science, medicine and health sciences in the field of pharmacy.X
3He/she knows the anatomy, immunology, physiology, physiopathology and biochemistry of biological systems. He/she knows the diseases affecting human health and fundamental concepts of therapy.X
4He/she has the sufficient knowledge to fulfill and assess the physical, chemical, toxicological, biological, microscopic, microbiological, molecular and elemental analysis of herbal drugs, biological and enviromental reference materials, food, food additives and contaminants, drug, active ingredient and excipients and medical products using scientific resources, pharmacopeis and validated methods.X
5He/she has knowledge and application capability on pre-formulation, formulation, laboratory, pilot batch and industrial scale productions, quality assurance, stability, storage, bioavailability, bioequivalance, drug authorization and patent studies of pharmaceutical products containing natural or synthetic active drug ingredient, biotechnological, nanotechnological, cosmetic, dermacosmetic and radiopharmaceutical products.X
6He/she possesses knowledge and application capability on recognition of drug targets, chemical structures, synthesis and analysis, effects, structure-activity relationships, design, development and determination of therapeutic dose of active drug ingredients with the knowledge on toxicological, pharmacokinetic and pharmacodynamic properties and side effects.X
7He/she has sufficient knowledge on magisterial preparations, usage and regulations of all original and generic drug products and medical products.X
8He/she has knowledge regarding the effects of drugs on biochemical parameters, drug-drug, food-drug, disease-drug interactions, following and preventing adverse drug effects, and pharmacovigilance.X
9He/she possesses knowledge and application capability on the subjects regarding pharmaceutics, phytopharmaceutics, biopharmaceutics, pharmaceutical care, pharmacotherapy, cosmetology, and clinical pharmacy.X
10He/she possesses the capability of giving and representing the prescribed drugs to the patient, assessing the clinical laboratory results, giving useful and practical information regarding the products such as dietary supplements, nutraceutics, health and diseases within the framework of rational drug use.X
11He/she identifies the medicinal and poisonous plants morphologically and by microscope. He/she has detailed knowledge on the secondary ingredient groups that present in medicinal plants.X
12He/she knows the effects of drugs and other chemical substances and biological and physical factors on the biological systems and enviroment, and toxicological risk assessment process. He/she possesses knowledge on the subjects regarding toxicity prevention and treatment approaches.X
13He/she possesses knowledge on the subjects regarding politics and economics of health intended to enhance public health and quality of life, drug, medical device, drug reimbursement and pharmacy management.X
14He/she is able to follow up national/international historical and up-to-date developments in the field of Pharmacy using technological tools, data base and source of information, assess data based on science and evidence, and adopt lifelong learning.X
15He/she is able to communicate effectively with the other professional groups and societies such as health legal authorithy, drug industry and professional organizations about the subjects regarding health, he/she is able to bring solutions and make suggestions for the problems regarding the professional field.X
16He/she possesses foreign language skill at a level to be able to communicate with the pofessional colleagues and patients for the profession of pharmacy.X
 -- NAME OF LECTURER(S)
   (Assos. Prof. Murat Kadir ŞÜKÜROĞLU)
 -- WEB SITE(S) OF LECTURER(S)
   (https://websitem.gazi.edu.tr/site/mkadir)
 -- EMAIL(S) OF LECTURER(S)
   (mkadir@gazi.edu.tr)