Istanbul Health and Technology University INFORMATION PACKAGE / COURSE CATALOGUE
| Pharmacy | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
Course General Introduction Information
| Course Code: | ECZ428 | ||||
| Course Name: | Pharmaceutical Biotechnology | ||||
| Course Semester: | Spring | ||||
| Course Credits: |
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| Language of instruction: | TR-EN | ||||
| Course Requirement: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Necessary | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator : | Dr.Öğr.Üyesi GENADA SİNANİ | ||||
| Course Lecturer(s): | |||||
| Course Assistants: |
Course Purpose and Content
| Course Objectives: | In this course, it is aimed to give information about pharmaceutical biotechnology and the production and properties of drugs prepared with this technology. |
| Course Content: | This course covers Recombinant DNA Technology, Upstream Process in the Production Process of Biotechnological Products, Downstream Process in the Production Process of Biotechnological Products, Controls of the Production Process of Biotechnological Products, Biotechnological Medicines, Biotechnological Medicines, Cytokines, Gene Drugs, Vaccines, Protein Peptide Formulation, Monoclonal Antibodies, Blood Products and Advanced Technology Products, Herbal biopharmaceuticals (Plant and tissue culture history, secondary metabolites and their derivation), Good manufacturing practices in pharmaceutical biotechnology/Patenting of recombinant pharmaceuticals and safety precautions. |
Learning Outcomes
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The students who have succeeded in this course;
1) Able to reach up-to-date information related to pharmaceutical sciences, and able to evaluate and apply into practice. 2) Able to provide any pharmaceutical information to patients, healthcare personnel and society. 3) Advanced knowledge about therapeutic activities, pharmaceutical forms, pharmacokinetics, and stability about active pharmaceutical ingredients. 4) Knowledge about all the topics and processes related to quality assurance. Able to do quality control and standardization. 5) Able to use the knowledge about medications and providing guidance to patients; able to make it sure safe and rational use of medications. 6) Knowledge about natural and synthetic active pharmaceutical ingredient production, production technologies. 7) Able to work in biotechnology and radiopharmaceutical product development and production. 8) Knowledge about patent protection, data protection and pharmaceutical product registration. 9) Able to develop himself/herself technically and administratively, in all the fields under the pharmacy profession’s legal responsibility; able to provide solutions to the problems through scientific data/evidence. 10) Able to use software and advanced technologies related to pharmaceutical field. 11) Able to follow and evaluate national or international developments related to pharmaceutical field. |
Course Flow Plan
| Week | Subject | Related Preparation |
| 1) | Recombinant DNA Technology | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 2) | Upstream process in the Production of Biotechnological Products | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 3) | Downstream process in the Production of Biotechnological Products | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 4) | Production Process Controls of Biotechnological Products | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 5) | Biotechnological Medicines | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 6) | Biotechnological Medicines | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 7) | Cytokines | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 8) | Midterm | - |
| 9) | Gene Medicines | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 10) | Vaccines | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 11) | Protein-Peptide Formulation | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 12) | Monoclonal Antibodies | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 13) | Blood Products and Advanced Technology Products | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 14) | Herbal biopharmaceuticals (History of plant and tissue culture, secondary metabolites and their derivation) | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 15) | Good manufacturing practices in pharmaceutical biotechnology/Patenting and safety measures of recombinant pharmaceuticals | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| 16) | Final Exam | - |
Sources
| Course Notes / Textbooks: | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
| References: | 1. Glick, B. R. And Pasternak, J. J. ‘Molecular Biotechnology’, ASM Press 1994, Washington D. C. 2. Biopharmaceuticals: Biochemistry and Biotechnology, Edit: Gary Walsh, Wiley 2002. 3. Biotechnology and Biopharmaceuticals: Transforming and Gene into Drıugs, Edit: Rodney J.Y. Ho, Milo Gibaldi, Wiley 2003. 4. Industrial Pharmaceutical Biotechnology, Edit: Heinrich Klefenz, Wiley-VCH 2005. 5. Pharmaceutical Biotechnology, Edit: Daan Crommelin, Robert Langer Tylor and Francis 2002. |
Course - Learning Outcome Relationship
| No Effect | 1 Lowest | 2 Medium | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Access, evaluate and apply up-to-date scientific knowledge in the field of pharmacy | 3 |
| 2) | It conveys information to patients, health personnel and society on all matters related to drugs. | 3 |
| 3) | Has the necessary knowledge about the therapeutic effects, drug forms, pharmacokinetic properties, stability and incompatibilities of drug active substances and can use this information. | 3 |
| 4) | Recognizes, controls and standardizes quality assurance issues and processes of all pharmaceutical-related products. | 3 |
| 5) | Has knowledge and equipment about the administration and use of the drug to the patient, advises on rational and safe drug use, and supports pharmacovigilance practices. | 3 |
| 6) | Has knowledge about the production and production technologies of natural and synthetic pharmaceutical raw materials. | 3 |
| 7) | Have knowledge about the concepts related to the functioning, maintenance and pathology of biological systems that form the basis of human health. | 3 |
| 8) | Has sufficient knowledge and application skills on research, development and production of pharmaceutical and cosmetic products. | 3 |
| 9) | Plans and implements all subjects within the scope of pharmacy services in the hospital. | 3 |
| 10) | Has knowledge about licensing conditions, data protection, patent and pharmacoeconomics in pharmaceuticals. | 3 |
| 11) | She/He is administratively and technically equipped in every field where the pharmacy profession is responsible by law, and produces solutions to problems in line with scientific data / evidence. | 3 |
| 12) | Combines basic and applied sciences with pharmacy profession practices and uses them in the field of pharmacy. | 3 |
| 13) | Has sufficient knowledge and application skills on physical, chemical, biological and toxicological analyzes of pharmaceutical, biotechnological and radiopharmaceutical products. | 3 |
| 14) | Acts in accordance with ethical and legal principles in the field of pharmacy. | 3 |
| 15) | Has the necessary competencies to work with colleagues and other health professionals in terms of communicative, managerial and social skills. | 3 |
| 16) | Provides consultancy on medicinal plants, herbal supplements and food supplements. | 3 |
| 17) | Knows pharmaceutical care practices, understands and evaluates drug interactions. | 3 |
| 18) | Knows the risks associated with the use of drugs and other chemical substances and laboratory practice. | 3 |
Learning Activity and Teaching Methods
| Alan Çalışması | |
| Anlatım | |
| Beyin fırtınası /Altı şapka | |
| Bireysel çalışma ve ödevi | |
| Course | |
| Grup çalışması ve ödevi | |
| Okuma | |
| Homework | |
| Problem Çözme | |
| Soru cevap/ Tartışma | |
| Uygulama (Modelleme, Tasarım, Maket, Simülasyon, Deney vs.) | |
| Web Tabanlı Öğrenme |
Measurement and Evaluation Methods and Criteria
| Yazılı Sınav (Açık uçlu sorular, çoktan seçmeli, doğru yanlış, eşleştirme, boşluk doldurma, sıralama) | |
| Homework | |
| Gözlem | |
| Bireysel Proje | |
| Grup Projesi | |
| Sunum | |
| Raporlama | |
| Bilgisayar Destekli Sunum |
Assessment & Grading
| Semester Requirements | Number of Activities | Level of Contribution |
| total | % | |
| PERCENTAGE OF SEMESTER WORK | % 0 | |
| PERCENTAGE OF FINAL WORK | % | |
| total | % | |
İş Yükü ve AKTS Kredisi Hesaplaması
| Activities | Number of Activities | Aktiviteye Hazırlık | Aktivitede Harçanan Süre | Aktivite Gereksinimi İçin Süre | Workload | ||
| Course Hours | 14 | 3 | 42 | ||||
| Study Hours Out of Class | 14 | 2 | 28 | ||||
| Homework Assignments | 3 | 4 | 12 | ||||
| Midterms | 1 | 2 | 2 | ||||
| Final | 1 | 2 | 2 | ||||
| Total Workload | 86 | ||||||