At the end of this course, the students; 1) Learns the purpose of drug targeting and targeting mechanisms. 2) Learn the preparation methods, production technologies, and characterization of drug delivery systems based on nanotechnology, such as microspheres, liposomes, niosomes, nanoparticles, and solid lipid nanoparticles. 3) Learns the basic concepts of pharmaceutical biotechnology, their importance in treatment and diagnosis, and the evaluation of the critical stages in the properties and formulations of biotechnological products. 4) Learns the concepts of biosimilarity, the development of biosimilar products, legal regulations according to TITCK, EMA, FDA. 5) Learns about the use and applications of different types of medical devices. Learns also the rules of legal regulations of these products 6) Learns all aspects of Good Manufacturing Practices (GMP) and quality assurance system in the production of pharmaceuticals in the pharmaceutical industry. 7) Provide information and consultancy to other health personnel, relevant institutions, and society with the knowledge and skills they have gained.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
None
COURSE DEFINITION
ECZ422 covers Drug Carrier Systems and Drug Targeting, Pharmaceutical Biotechnology, Medical Device used in diagnosis and treatment, Good Manufacturing Practices (GMP) and Quality Assurance.
COURSE CONTENTS
WEEK
TOPICS
1st Week
Targeting Drugs and Targeting Mechanisms
2nd Week
Drug Carrier Systems and Drug Targeting
3rd Week
Drug Carrier Systems (liposomes, niosomes)
4th Week
Drug Carrier Systems (microsphere, nanoparticle, solid lipid nanoparticle),
5th Week
Pharmaceutical Biotechnology (Basic concepts of pharmaceutical biotechnology, its importance in treatment and diagnosis)
6th Week
Pharmaceutical Biotechnology (Properties and formulations of biotechnological products and vaccines produced with recombinant DNA and monoclonal antibody technology)
7th Week
MID TERM EXAMINATION
8th Week
Pharmaceutical Biotechnology (Development of formulations of peptides and proteins)
9th Week
Pharmaceutical Biotechnology (The concept of biosimilarity, development of biosimilar products)
10th Week
Medical Device Classification, uses and legal regulations
11th Week
Medical Device Classification, uses and legal regulations/Radiopharmaceuticals
12th Week
Radiopharmaceuticals
13th Week
Good Manufacturing Practices (GMP) and Quality Assurance
14th Week
Good Manufacturing Practices (GMP) and Quality Assurance
RECOMENDED OR REQUIRED READING
1. Lecture notes 2. Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi Yayını (Acartürk,F., Ağabeyoğlu,İ., Çelebi,N., Değim, T., Değim, Z.,Doğanay,T.,Takka,S., Tırnaksız,F.,), 2007. 3. Farmasötik Teknoloji, Temel Konular ve Dozaj Şekilleri, Gürsoy, A., (Ed), İstanbul, I. Baskı, Kontrollü Salım Sistemleri Derneği Yayını No:2, 2004. 4. Physical Pharmacy (Editör: Alfred Martin) (Lea&Febriger, ABD, 1993.
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Mid-term
1
40
Total(%)
40
Contribution of In-term Studies to Overall Grade(%)
40
Contribution of Final Examination to Overall Grade(%)
60
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
1
2
2
Preparation for Quiz
0
0
0
Individual or group work
14
2
28
Preparation for Final exam
1
12
12
Course hours
14
2
28
Preparation for Midterm exam
1
12
12
Laboratory (including preparation)
0
0
0
Final exam
1
3
3
Homework
1
6
6
Total Workload
91
Total Workload / 30
3,03
ECTS Credits of the Course
3
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)
