TÜRKÇE
ENGLISH
Information
| Code | MTH007 |
| Name | Introduction to the Pharmaceutical Industry (Deva Holding) |
| Term | 2023-2024 Academic Year |
| Semester | 7. Semester |
| Duration (T+A) | 1-0 (T-A) (17 Week) |
| ECTS | 1 ECTS |
| National Credit | 1 National Credit |
| Teaching Language | Belirsiz |
| Level | Lisans Dersi |
| Type | Normal |
| Mode of study | Uzaktan Öğretim |
| Catalog Information Coordinator | |
| Course Instructor |
Dr. Öğr. Üyesi ZEYNEP ÖZDEMİR KÜTAHYA
(A Group)
(Ins. in Charge)
|
Course Goal / Objective
The aims of this course are; To provide students with general information about the Pharmaceutical Industry, patented production methods and strategies to overcome unit formulas in the pharmaceutical patent and generic drug development stages, active ingredient selection, studies that need to be done for the development of specific drug dosage forms, and critical points for successful Bio-Equivalence studies.
Course Content
Pharma industry in Türkiye and the World, The importance of generic drug development, Drug Patents and methods to overcome them, R&D processes in generic drug development, Active Substance-Excipient interactions and Analytical methods for them, The importance of Polymorphism in Drugs, QBD approach in drug development and successful Biotechnology -Strategies for equivalence studies will be given. Solutions to the problems encountered during drug development and production will be given with case studies.
Course Precondition
The course has no prerequisites.
Resources
Farmasotik Teknoloji
Notes
ICH Guideline, EMA
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Have knowledge about the pharma industry in Türkiye and the world. |
| LO02 | Have knowledge about patent and patent in pharmaceuticals. |
| LO03 | Know R&D processes in drug development. |
| LO04 | Have knowledge about active ingredient selection and interaction with excipients in drug development. |
| LO05 | Develop strategies for successful formulations. |
| LO06 | Have knowledge about analytical methods in drug analysis and their development. |
| LO07 | Have knowledge about QBD approach and BE in drug development. |
| LO08 | Know GMP and GLP concepts. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Learns animal species and breeds, recognizes structural, functional and behavioral characteristics (anatomical, histological, physiological, biochemical, etc.). | |
| PLO02 | Bilgi - Kuramsal, Olgusal | It determines the care and nutrition alternatives for healthy aquaculture and prepares feeding programs suitable for the purpose in accordance with the cultivation patterns and expected yield characteristics of different animal species. | |
| PLO03 | Bilgi - Kuramsal, Olgusal | Determine the diagnosis and treatment protocols of diseases. | |
| PLO04 | Bilgi - Kuramsal, Olgusal | Learns basic information about chemical and biological substances to be used for prevention and treatment of diseases and their production technologies. | 5 |
| PLO05 | Bilgi - Kuramsal, Olgusal | Evaluates the efficiency of animal breeds. Learns the level of animal breeding. Able to manage an animal selection, hybridization and artificial insemination program. | |
| PLO06 | Bilgi - Kuramsal, Olgusal | Makes the most appropriate management planning for livestock enterprises. | |
| PLO07 | Bilgi - Kuramsal, Olgusal | Has knowledge about animal rights and animal owner rights. | |
| PLO08 | Bilgi - Kuramsal, Olgusal | Has sufficient technology knowledge about hygienic production, production, presentation and sales of animal foods produced for human consumption and / or products of animal products. | |
| PLO09 | Bilgi - Kuramsal, Olgusal | Learns national and international laws and regulations related to veterinary medicine. | |
| PLO10 | Bilgi - Kuramsal, Olgusal | A veterinary practitioner manages animal husbandry enterprises, animal husbandry scientific research centers and animal food production enterprises by utilizing the knowledge gained in the veterinary medicine education and by observing the professional principles. | |
| PLO11 | Bilgi - Kuramsal, Olgusal | Recognizes all kinds of diseases that are possible in animals, uses diagnostic methods for this purpose, receives diagnostic materials if necessary and sends them to authorized laboratories and treats the diseases diagnosed by using all methods of medicine (such as interpretation of diagnostic methods results, drug or operative applications). It takes necessary security measures including biosecurity for the control of infectious diseases. | |
| PLO12 | Bilgi - Kuramsal, Olgusal | Prepares and uses the theoretical maintenance-feed protocols. Makes necessary applications for economic aquaculture by considering the characteristics at the business and regional level. | |
| PLO13 | Bilgi - Kuramsal, Olgusal | Inspects the production of animal foods and products of animal origin which produced for human consumption and performs health control of the final foodstuffs. | |
| PLO14 | Bilgi - Kuramsal, Olgusal | Being aware of the duties and responsibilities to have the consciousness of exercising the profession. Takes responsibility in individual and group work, fulfills the task in line with the skills. | 3 |
| PLO15 | Bilgi - Kuramsal, Olgusal | In cooperation with other experts in problems outside the field of expertise, the team contributes to the solution as a member. Also trying to find solutions to common problems at the regional or national level as well as communication with other professionals. | 3 |
| PLO16 | Beceriler - Bilişsel, Uygulamalı | Comprehends the methods of producing and using scientific knowledge. Evaluates the knowledge and skills gained in a critical way, identifies the new information and information sources that should be acquired in relation to the field and participates in the activities that will meet the learning needs. | 3 |
| PLO17 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Takes tasks related to the field in professional councils and organizations. Based on his professional skills and competences, he plans and realizes social projects with the awareness of society. Provides information on the problems of public and animal health related to the definition of the problem and the solution proposals and organizes events. | |
| PLO18 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | He / she can continue his / her professional development and use at least one foreign language (at least European Language Portfolio B1 general level) to establish social relations. At least at the Advanced Level of European Computer Driving License, it uses computer software and other technological tools that may be needed at professional level and social relations level. He follows the world agenda closely and is sensitive to events. | 2 |
| PLO19 | Yetkinlikler - Öğrenme Yetkinliği | Be aware of the needs of the country and the region, and if necessary, guide them in their practice. It defines the subject of human, animal and animal owner rights and considers animal welfare in all its practices. They have the ethical values that are required by the profession, and defend these values when necessary. Have the competence to practice and defense, dominate the concepts of occupational safety in terms of work place and the personnel working with it. It is aware of the environmental health rules and makes practices to protect nature. The environment is sensitive to veterinary public health and zoonoses. | |
| PLO20 | Yetkinlikler - Öğrenme Yetkinliği | Conceptualize the facts and events related to veterinary services; examine scientific techniques and methods, interpret the results; constructs analysis or methods for problems; provides solutions and / or treatment alternatives according to the data obtained. Follows the legislation that is updated on veterinary services and uses them when necessary. | |
| PLO21 | Bilgi - Kuramsal, Olgusal | Evaluate the physiological and physiopathological conditions of animals conceptually and factually. | |
| PLO22 | Yetkinlikler - Alana Özgü Yetkinlik | Evaluates the laboratory results (hematological, biochemical, EKG, EEG, EMG, etc.) of animal diseases and applies correct diagnosis, diagnosis and treatment methods based on the data obtained. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Pharma Industry in Türkiye and the World | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | Generic and originator drugs, the importance of generic drugs | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | GMP, GLP | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | Departments and responsibilities in the pharmaceutical industry | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Patent in pharma - 1 | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | Patent in pharma-2 | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | R&D processes in the pharmaceutical industry | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 9 | Active ingredient selection | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Active ingredient-excipient interactions | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Polymorphism | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | QBD approach in drug development | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Development of specific drug doses | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | Analytical method validation studies | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Bioavailability and bioequivalence | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 17 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 1 | 14 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 2 | 2 |
| Final Exam | 1 | 4 | 4 |
| Total Workload (Hour) | 34 | ||
| Total Workload / 25 (h) | 1,36 | ||
| ECTS | 1 ECTS | ||