EAG616 - TECHNOLOGY and REGULATIONS of PHARMACEUTICAL DOSAG

Course Name Code Semester Theory
(hours/week)		 Application
(hours/week)		 Credit ECTS
TECHNOLOGY and REGULATIONS of PHARMACEUTICAL DOSAG EAG616 Any Semester/Year 3 0 3 5
Prequisites
Course languageTurkish
Course typeElective 
Mode of DeliveryFace-to-Face 
Learning and teaching strategiesLecture
Discussion
Preparing and/or Presenting Reports
 
Instructor (s)Prof.Dr. SIBEL PEHLIVAN, Prof.Dr. IMRAN VURAL, Doç.Dr. TUGBA GÃœLSÃœN INAL, Prof.Dr. HAKAN EROGLU, Prof.Dr. BETÃœL ARICA YEGIN, Prof.Dr. SEVDA SENEL, Prof.Dr. SELMA SAHIN  
Course objectiveIn the preparation and evaluation of drug registration documents, subjects of pharmaceutical technology have importance. The objective of this course is to teach students and give them the required perspective to follow the latest developments in the preparation of drug registration documents, evaluation and conclusion of the registrations steps. 
Learning outcomes
  1. On successful completion of this course, students have technical experience about the preparation, evaluation and conclusion of registration documents from pharmaceutical technology perspective.
Course ContentPreparation of registration sections, their evaluation from regulatory and technological aspects. 
ReferencesLecture notes, general references of Pharmaceutical Technology, articles, ICH guidelines, EC directives, FDA directives 

Course outline weekly

WeeksTopics
Week 1Formulation studies related to pharmaceutical dosage forms.
Week 2Production Technologies related to pharmaceutical dosage forms: Parenteral dosage forms Design of production facilities, pproperties of production facilities, air classification system, HEPA filters, laminar flow systems.
Week 3Production Technologies related to pharmaceutical dosage forms: Solid dosage forms: Design of production facilities, Storage units for raw material and finished products, Production, In process controls and package design
Week 4Stability in pharmaceutical dosage forms Description, stability tests, stability guides, information about the product, fotostability tests, batch selection, packing system, specifications, test frequency, guarantee of stability, data analysis, label
Week 5In vivo studies for pharmaceutical dosage forms ? I: Bioavailability and Bioequivalancy, Parameters affecting bioavailability, BA/BE study design, Parameters to determine, BE acceptance criteria
Week 6In vivo studies for pharmaceutical dosage forms ? II: Biopharmaceutical Classification System (BCS), Bio-exemption according to BCS
Week 7Midterm exam
Week 8Good Manufacturing Practice (cGMP)-I: GMP description, Basic principals of GMP, How to build GMP
Week 9Good Manufacturing Practice (cGMP)-II: GMP guidelines, GMP certification
Week 10Regulatory applications in Turkey,Regulation procedures
Week 11Regulation studies in the world: Regulatory procedures and guidelines of EMA, FDA and other countries, - ICH, WHO regulations
Week 12Intellectual Property Rights-I: Innovation, patent, criteria, patent, useful models, Patent process in Turkey, Europe and USA
Week 13Intellectual Property Rights-II: Types of patent application types, legal regulations, patent research, brand, industrial desig
Week 14Discussion
Week 15Recovery
Week 16Final exam

Assesment methods

Course activitiesNumberPercentage
Attendance00
Laboratory00
Application00
Field activities00
Specific practical training00
Assignments125
Presentation00
Project00
Seminar00
Midterms125
Final exam150
Total100
Percentage of semester activities contributing grade succes250
Percentage of final exam contributing grade succes150
Total100

WORKLOAD AND ECTS CALCULATION

Activities Number Duration (hour) Total Work Load
Course Duration (x14) 14 3 42
Laboratory 0 0 0
Application000
Specific practical training000
Field activities000
Study Hours Out of Class (Preliminary work, reinforcement, ect)14456
Presentation / Seminar Preparation31030
Project000
Homework assignment000
Midterms (Study duration)11010
Final Exam (Study duration) 11212
Total Workload3339150

Matrix Of The Course Learning Outcomes Versus Program Outcomes

D.9. Key Learning OutcomesContrubition level*
12345
1. Has knowledge in the area of preformulation and formulation designs about industrial production, quality control, quality assurance system and stability    X
2. Acquires information about nanotechnology, new drug delivery systems and controlled release systems    X
3. Learns to keep track of up to date literature and patents using the knowledge and informatics technologies  X  
4. Interprets the guidelines of health authorities such as FDA, EMA and international guidelines such as GMP, ANDA, BA/BE, QA/QC, acquires application knowledge and skills   X 
5. Has knowledge to understand and interpret chemical, instrumental and pharmacological dataX    
6. Has basic concepts about medicinal chemistry such as design of new drug molecules, drug-receptor interactions     
7. Has the knowledge on the rules of scientific ethics which should be complied  X  
8. Effectively uses the conventional and new synthetic methods.     
9. Has knowledge of advanced toxicity tests accepted by regulatory authorities     
10. Has knowledge about pharmacological experimental methods and their applications used in drug research and evaluates analysis results     
11. Has knowledge about preclinical and clinical drug research  X  
12. Has knowledge about the pharmacokinetic and pharmacodynamic properties of drugs X   
13. Has knowledge about the pharmacokinetics and pharmacodynamics of drugs X   
14. Has knowledge of and the ability to use the devices and instruments used in the application of instrumental analysis methods X   
15. Has the ability to apply theoretical and practical knowledge in the analysis of substances in medicinal products and biological materials X   

*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest