| Pharmacy | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
| Course Code: | ECZ408 | ||||
| Course Name: | Pharmaceutical Biotechnology | ||||
| Semester: | Spring | ||||
| Course Credits: |
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| Language of instruction: | Turkish | ||||
| Course Condition: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Compulsory Courses | ||||
| Course Level: |
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| Mode of Delivery: | E-Learning | ||||
| Course Coordinator: | Dr. Öğr. Üy. ECE ÖZCAN BÜLBÜL | ||||
| Course Lecturer(s): | Pharm. Dr. Ece Özcan Bülbül | ||||
| Course Assistants: |
| Course Objectives: | The aim of the course is to provide the students present information about basic topics in pharmaceutical biotechnology, properties of biotechnological drugs, production technologies, analysis of biotechnological products. |
| Course Content: | This course includes basic concepts in pharmaceutical biotechnology, structure of biotechnological drugs, recombinant DNA technology, production of biotechnological drugs, analytical methods of biotechnological drugs, cytokines, growth factors, therapeutic hormones, recombinant blood products and therapeutic enzymes, monoclonal antibodies, biotechnological vaccines, gene therapy, biosimilar drugs. |
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The students who have succeeded in this course;
1) Knows the basic concepts in pharmaceutical biotechnology and explains biotechnological drugs. 2) Knows the structure of biotechnological drugs. 3) Has knowledge about recombinant DNA technology, production, and analysis of biotechnological drugs. 4) Be able to give examples of biotechnological products 5) Has knowledge about biotechnological vaccines. 6) Has knowledge about gene therapy. 7) Has knowledge about biosimilar drugs. |
| Week | Subject | Related Preparation |
| 1) | Basic Concepts in Pharmaceutical Biotechnology | |
| 2) | Structure of Biotechnological Drugs | |
| 3) | Recombinant DNA Technology | |
| 4) | Production of Biotechnological Drugs-1 | |
| 5) | Production of Biotechnological Drugs-2 | |
| 6) | Analysis Methods of Biotechnological Drugs | |
| 7) | Cytokines | |
| 8) | Growth Factors | |
| 9) | Therapeutic Hormones | |
| 10) | Recombinant Blood Products and Therapeutic Enzymes | |
| 11) | Monoclonal Antibodies | |
| 12) | Biotechnological Vaccines | |
| 13) | Gene Therapy | |
| 14) | Biosimilar Drugs |
| Course Notes / Textbooks: | 1- Walsh G., Pharmaceutical Biotechnology: Concepts and Applications, Wiley, 2007. 2- Crommelin DJA., Sindelar RD., Meibohm B., Pharmaceutical Biotechnology: Fundamentals and Applications, Springer, 2019 (5th edition). 3-Gad SC., Handbook of Pharmaceutical Biotechnology, Wiley, 2007. 4-Glick BR., Pasternak JJ., Patten CL., Molecular Biotechnology: Principles and Applications of Recombinant DNA, ASM Press, 2009 (4th edition). 5- Biyoteknolojik İlaçlar (Biyolojik ve Biyoteknolojik olarak Biyobenzer Ürünlerin Üretimi, Kalitesi, Preklinik - Klinik Çalışmaları ve Güvenliliği), İskit A, Dora DD, Çiçin İ, Kılıç L, Ar MR, Kiraz S, Şardaş S. Araştırmacıları İlaç Firmaları Derneği (AIFD), 2020. |
| References: | 1- Walsh G., Pharmaceutical Biotechnology : Concepts and Applications, Wiley , 2007. 2- Crommelin DJA., Sindelar RD., Meibohm B., Pharmaceutical Biotechnology : Fundamentals and Applications, Springer , 2019 (5th edition ). 3-Gad SC., Handbook of Pharmaceutical Biotechnology, Wiley, 2007. 4-Glick BR., Pasternak JJ., Patten CL., Molecular Biotechnology: Principles and Applications of Recombinant DNA, ASM Press, 2009 (4th edition ). 5- Biyoteknolojik İlaçlar (Biyolojik ve Biyoteknolojik olarak Biyobenzer Ürünlerin Üretimi, Kalitesi, Preklinik - Klinik Çalışmaları ve Güvenliliği), İskit A, Dora DD, Çiçin İ, Kılıç L, Ar MR, Kiraz S, Şardaş S. Araştırmacıları İlaç Firmaları Derneği (AIFD), 2020. - Crommelin DJA, Sindelar RD., Meibohm B., Pharmaceutical Biotechnology : Fundamentals and Applications, Springer-Verlag New York, 2013 |
| Course Learning Outcomes | 1 |
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3 |
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6 |
7 |
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| Program Outcomes | |||||||||||
| 1) Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||
| 2) Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||
| 3) Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | 1 | ||||||||||
| 4) Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | 1 | ||||||||||
| 5) Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |||||||||||
| 6) Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | 1 | 1 | |||||||||
| 7) Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | 2 | ||||||||||
| 8) He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | 2 | 2 | 2 | 2 | 2 | 2 | 3 | ||||
| 9) Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | |||||||||||
| 10) As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | ||||
| 11) He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | ||||
| No Effect | 1 Lowest | 2 Average | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 1 |
| 2) | Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 1 |
| 3) | Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |
| 4) | Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | |
| 5) | Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |
| 6) | Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |
| 7) | Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |
| 8) | He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | 2 |
| 9) | Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | |
| 10) | As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 |
| 11) | He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 |
| Semester Requirements | Number of Activities | Level of Contribution |
| Midterms | 1 | % 30 |
| Final | 1 | % 70 |
| total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 30 | |
| PERCENTAGE OF FINAL WORK | % 70 | |
| total | % 100 | |
| Activities | Number of Activities | Workload |
| Course Hours | 14 | 28 |
| Study Hours Out of Class | 14 | 28 |
| Midterms | 1 | 1 |
| Final | 1 | 1 |
| Total Workload | 58 | |