Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
9303115392011Phytopharmaceutical Drug Manufacturing and Quality Control Elective116
Level of Course Unit
Second Cycle
Objectives of the Course
to learn the necessary information for the preparation of quality control, standardization of phytopharmaceuticals and licensing of dosage forms,
Name of Lecturer(s)
Learning Outcomes
1Fitofarmasötiklerin prensiplerini öğrenme
2Fitofarmasötiklerde kalite kontrol ve stabiliteyi öğrenme ve yorumlama
3Fitofarmasötik dozaj şekillerini öğrenip, yorumlama
4Fitofarmasötiklerin ruhsatlandırma süreçlerini öğrenme
5Bitkisel ürünlerde farmakovijilansı öğrenip yorumlama
6Learn the principles of Phytopharmaceutical Processes,
7Quality control and stability of Phytopharmaceuticals, learn, interpret
8Learn the principles of Phytopharmaceutical dosage forms
9Pharmacovigilans of Herbal Medicines , learn, interpret
10Learn The marketing authorisation system of Herbal Medicinal Products
Mode of Delivery
Face to Face
Prerequisites and co-requisities
None
Recommended Optional Programme Components
None
Course Contents
Phytopharmaceutics, dosage forms, analysis and standardization of phytochemical, pharmacological screening tests, quality control and stability testing of phytopharmaceutics, licensing, efficacy and safety, pharmacovigilance and phytoequivalence
Weekly Detailed Course Contents
WeekTheoreticalPracticeLaboratory
1Phyrotherapy and Phytopharmaceuticals
2Guidince and Monographs
3Starting material
4Phytoconstituents and Their analysis
5Labelling of Herbal drug preparations
6Pharmacological screening of Herbal Drugs
7Dosage Forms
8Mid-exam
9Good Manufacturing Practice (GMP)
10Quality Assurance of Phytopharmaceuticals
11Stability testing Herbal drugs
12Efficacy and safety of Herbal Medicinal products
13The marketing authorisation system of Herbal Medicinal Products
14Pharmacovigilans of Herbal Medicines
15Phytoequivalence
16Final exam
Recommended or Required Reading
Herbal Medicinal Products; Frauke Daedcke, Barbara Steinhoff, Medpharm, 2003 Phytopharmacetical Technology, P.H. List, P.C. Schmit, Heyden&Son 1989
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
Term (or Year) Learning ActivitiesQuantityWeight
SUM0
End Of Term (or Year) Learning ActivitiesQuantityWeight
SUM0
SUM0
Language of Instruction
Turkish
Work Placement(s)
None
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination122
Final Examination122
Attending Lectures14228
Practice000
Report Preparation000
Report Presentation000
Criticising Paper000
Self Study000
Individual Study for Mid term Examination13030
Individual Study for Final Examination13030
TOTAL WORKLOAD (hours)92
Contribution of Learning Outcomes to Programme Outcomes
PO
1
PO
2
PO
3
PO
4
PO
5
PO
6
PO
7
PO
8
PO
9
PO
10
LO1          
LO2          
LO3          
LO4          
LO5          
LO64         
LO7 3        
LO8  4   3 34
LO9   4 3 4  
LO10    3     
* Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High
 
Ege University, Bornova - İzmir / TURKEY • Phone: +90 232 311 10 10 • e-mail: intrec@mail.ege.edu.tr