Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
300005892019PHARMACEUTICAL DEVELOPMENT IN INDUSTRIAL PHARMACEUTICS/ MEDCAL DEVICE MANUFACTURINGElective593
Level of Course Unit
First Cycle and Second Cycle
Language of Instruction
Objectives of the Course
The aim of this course is to have information about chemical, pharmaceutical and biological data that must be provided about the active substance (s) and the finished medicinal product. Development, manufacturing process, product characteristics and features, quality control management and conditions, the ability to explain the stability and composition of the finished medicinal product.
Name of Lecturer(s)
Tüm öğretim üyeleri
Learning Outcomes
11- To be able to define active substances which is suitable for pharmaceutical use and to comprehend their properties, 2- To be able to comprehend and comment on the necessary chemical, pharmaceutical and biological data related to the finished medicinal product, 3- To have knowledge about the development of pharmaceutical product, manufacturing process, product characteristics and properties 4- To have knowledge about quality control management and conditions of pharmaceutical products 5- To be able to explain the stability and composition of the finished medicinal product
Mode of Delivery
Face to Face
Prerequisites and co-requisities
No prerequisites
Recommended Optional Programme Components
There is none
Course Contents
Development, manufacturing process, product characteristics and properties, quality control management and conditions, stability and composition of the finished medicinal product
Weekly Detailed Course Contents
WeekTheoreticalPracticeLaboratory
1Pharmaceutical active ingredients
2Original and generic drugs
3Development of drug formulations
4Development of product process
5Drug production in industry
6Control of excipients
7Control of commercial drugs
8Stability tests
9Licencing of human medical products
10Medical device development
11Medical device regulations
12Midterm
13Production facilities and equipment
14Good manufacturing practises
15An example of a production scheme
16Final examination
Recommended or Required Reading
ICH Guides TITCK guidelines and regulations FDA and EMA contents
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
Term (or Year) Learning ActivitiesQuantityWeight
Midterm Examination1100
SUM100
End Of Term (or Year) Learning ActivitiesQuantityWeight
Final Sınavı1100
SUM100
Term (or Year) Learning Activities40
End Of Term (or Year) Learning Activities60
SUM100
Work Placement(s)
There is none
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination11.51.5
Final Examination12.52.5
Individual Study for Homework Problems11515
Individual Study for Mid term Examination12020
Individual Study for Final Examination14040
TOTAL WORKLOAD (hours)79.0
Contribution of Learning Outcomes to Programme Outcomes
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* 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