GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
R&D AND SCALE UP IN THE DRUG MANUFACTURING ON INDUSTRY/ECZ 5659
Course Title: R&D AND SCALE UP IN THE DRUG MANUFACTURING ON INDUSTRY
Credits 2 ECTS 4
Course Semester 9 Type of The Course Elective
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
Learns knowledge and concepts to develop pharmaceutical product
Learns effective parameters which affets the drug formulations
Learns the development of generic formulations and new drug design
Learns dimensional analysis and scale up principles in industrial applications and theories
Gains knowledge and skills in areas related to industrial pharmacy, follows the developments, transfers the information to the industrial pharmacy
Learns the process required to develop a generic drug formulation and the information about the tests performed for this purpose
Learns how scaling of developed products with R&D studies, required calculations and technology transfer
 -- MODE OF DELIVERY
  The mode of delivery of this course is face to face
 --WEEKLY SCHEDULE
1. Week  Definitions and necessity of research in the development of pharmaceutical formulations
2. Week  Important points to consider when changing from pilot batch production to the actual production bathces
3. Week  Research on effective collaboration to keep the product quality and performance
4. Week  Pharmaceutical scale up process in developing a new drug design and generic formulation
5. Week  Dimensional analysis and scale up in industrial applications and theory
6. Week  Scale up of parenteral drugs
7. Week  Scale up of non parenterals, liquids and semisolids, Midterm exam
8. Week  Increasing batch size in dry grinding and mixing
9. Week  Scale up in granulation and drying
10. Week  Increasing batch size for granulation using fludized bed
11. Week  Scale up for capsules
12. Week  Scale up for tablet production
13. Week  Scale up calculations in tablet production
14. Week  Scale up for film coating
15. Week  
16. Week  
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
50
 Assignment
1
50
 Application
0
0
 Projects
0
0
 Practice
0
0
 Quiz
0
0
 Percent of In-term Studies  
50
 Percentage of Final Exam to Total Score  
50
 -- WORKLOAD
 Activity  Total Number of Weeks  Duration (weekly hour)  Total Period Work Load
 Weekly Theoretical Course Hours
14
3
42
 Weekly Tutorial Hours
0
 Reading Tasks
10
2
20
 Searching in Internet and Library
4
3
12
 Material Design and Implementation
2
2
4
 Report Preparing
3
2
6
 Preparing a Presentation
4
1
4
 Presentation
1
1
1
 Midterm Exam and Preperation for Midterm Exam
1
5
5
 Final Exam and Preperation for Final Exam
2
3
6
 Other (should be emphasized)
0
 TOTAL WORKLOAD: 
100
 TOTAL WORKLOAD / 25: 
4
 Course Credit (ECTS): 
4
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1Completing Bachelor Degree in Pharmacy, the Bachelor of Science graduate is able to apply his/her gained knowledge and skills to all of the fields of Pharmacy profession within the framework of law, regulations, principles, professional values and ethical rules.X
2Combining with the applications regarding Pharmacy profession, he/she is able to use the concepts and applications of fundamental science, medicine and health sciences in the field of pharmacy.X
3He/she knows the anatomy, immunology, physiology, physiopathology and biochemistry of biological systems. He/she knows the diseases affecting human health and fundamental concepts of therapy.X
4He/she has the sufficient knowledge to fulfill and assess the physical, chemical, toxicological, biological, microscopic, microbiological, molecular and elemental analysis of herbal drugs, biological and enviromental reference materials, food, food additives and contaminants, drug, active ingredient and excipients and medical products using scientific resources, pharmacopeis and validated methods.X
5He/she has knowledge and application capability on pre-formulation, formulation, laboratory, pilot batch and industrial scale productions, quality assurance, stability, storage, bioavailability, bioequivalance, drug authorization and patent studies of pharmaceutical products containing natural or synthetic active drug ingredient, biotechnological, nanotechnological, cosmetic, dermacosmetic and radiopharmaceutical products.X
6He/she possesses knowledge and application capability on recognition of drug targets, chemical structures, synthesis and analysis, effects, structure-activity relationships, design, development and determination of therapeutic dose of active drug ingredients with the knowledge on toxicological, pharmacokinetic and pharmacodynamic properties and side effects.X
7He/she has sufficient knowledge on magisterial preparations, usage and regulations of all original and generic drug products and medical products.X
8He/she has knowledge regarding the effects of drugs on biochemical parameters, drug-drug, food-drug, disease-drug interactions, following and preventing adverse drug effects, and pharmacovigilance.X
9He/she possesses knowledge and application capability on the subjects regarding pharmaceutics, phytopharmaceutics, biopharmaceutics, pharmaceutical care, pharmacotherapy, cosmetology, and clinical pharmacy.X
10He/she possesses the capability of giving and representing the prescribed drugs to the patient, assessing the clinical laboratory results, giving useful and practical information regarding the products such as dietary supplements, nutraceutics, health and diseases within the framework of rational drug use.X
11He/she identifies the medicinal and poisonous plants morphologically and by microscope. He/she has detailed knowledge on the secondary ingredient groups that present in medicinal plants.X
12He/she knows the effects of drugs and other chemical substances and biological and physical factors on the biological systems and enviroment, and toxicological risk assessment process. He/she possesses knowledge on the subjects regarding toxicity prevention and treatment approaches.X
13He/she possesses knowledge on the subjects regarding politics and economics of health intended to enhance public health and quality of life, drug, medical device, drug reimbursement and pharmacy management.X
14He/she is able to follow up national/international historical and up-to-date developments in the field of Pharmacy using technological tools, data base and source of information, assess data based on science and evidence, and adopt lifelong learning.X
15He/she is able to communicate effectively with the other professional groups and societies such as health legal authorithy, drug industry and professional organizations about the subjects regarding health, he/she is able to bring solutions and make suggestions for the problems regarding the professional field.X
16He/she possesses foreign language skill at a level to be able to communicate with the pofessional colleagues and patients for the profession of pharmacy.X
 -- NAME OF LECTURER(S)
   (Prof.Dr. Füsun Acartürk , Assoc.Prof. Sibel İlbasmış Tamer , Assoc.Prof. Fatmanur Tuğcu Demiröz , )
 -- WEB SITE(S) OF LECTURER(S)
   (https://websitem.gazi.edu.tr/site/acarturk , https://websitem.gazi.edu.tr/site/ilbasmis , https://websitem.gazi.edu.tr/site/fatmanur , )
 -- EMAIL(S) OF LECTURER(S)
   (acarturk@gazi.edu.tr , ilbasmis@gazi.edu.tr , fatmanur@gazi.edu.tr )