GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
EVALUATION OF BIOAVAILABILITY AND BIOEQUIVALENCE IN PHARMACEUTICAL DOSAGE FORMS/EE-1100
Course Title: EVALUATION OF BIOAVAILABILITY AND BIOEQUIVALENCE IN PHARMACEUTICAL DOSAGE FORMS
Credits 3 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, tincecayir@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learning the design and evaluation of BA/BE in drug development
Learning area under the plasma curve (AUC), maximum plasma concentration (Cmax) concepts and calculations for bioequivalence
Evaluation of in vitro dissolution profiles and learning the fundamentals of biopharmaceutics classification system (BCS)
 -- MODE OF DELIVERY
  Face to face
 -- PREREQUISITES AND CO-REQUISITES
  Non existing
 -- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS
  There is no recommended optional programme component for this course
 --COURSE CONTENT
1. Week  Basic concepts of drug dissolution
2. Week  The dissolution methods and profiles of pharamaceutical dosage forms and its evaluation
3. Week  The dissolution methods and profiles of pharamaceutical dosage forms and its evaluation
4. Week  Difference (f1) and similarity (f2) factors and statistical methods
5. Week  The Biopharmaceutics Classification System (BCS)
6. Week  The Biopharmaceutics Drug Disposition Classification System (BDDCS)
7. Week  The fundamentals and basic concepts in bioavailability and bioequivalence
8. Week  The design and evaluation of BA/BE study for immediate release dosage forms
9. Week  The design and evaluation of BA/BE study for controlled release dosage forms
10. Week  The design and evaluation of BA/BE study in fast state, fed state and steady state conditions
11. Week  The design and evaluation of BA/BE study for highly variable drugs
12. Week  Criteria of biowaiver
13. Week  The concept and evaluation of BA/BE in biotechnological products
14. Week  Biosimilarity concept
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy Guidelines, FDA guidelines, EMEA guidelines, ICH guidelines, The European Pharmacopoeia, American Pharmacopoeia
 -- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
  Lecture,Demonstration, Drill - Practise
 -- WORK PLACEMENT(S)
  -
 -- ASSESSMENT METHODS AND CRITERIA
 
Quantity
Percentage
 Mid-terms
1
0
 Assignment
1
10
 Exercises
0
0
 Projects
0
40
 Practice
0
0
 Quiz
0
0
 Contribution of In-term Studies to Overall Grade  
50
 Contribution of Final Examination to Overall Grade  
50
 -- 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
10
4
40
 Searching in Internet and Library
8
4
32
 Designing and Applying Materials
0
 Preparing Reports
6
5
30
 Preparing Presentation
4
4
16
 Presentation
4
3
12
 Mid-Term and Studying for Mid-Term
1
7
7
 Final and Studying for Final
1
10
10
 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.
11Develops new approaches to potential problems and bring solutions by using the knowledge in the releated area.X