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Biological Drugs
Study Course Description
Course Description Statuss:Approved
Course Description Version:2.00
Study Course Accepted:19.01.2022 16:41:24
| Study Course Information | |||||||||
| Course Code: | FKK_040 | LQF level: | Level 7 | ||||||
| Credit Points: | 2.00 | ECTS: | 3.00 | ||||||
| Branch of Science: | Basic Sciences of Medicine, including Pharmacy | Target Audience: | Pharmacy | ||||||
| Study Course Supervisor | |||||||||
| Course Supervisor: | Renāte Ranka | ||||||||
| Study Course Implementer | |||||||||
| Structural Unit: | Department of Pharmaceutical Chemistry | ||||||||
| The Head of Structural Unit: | |||||||||
| Contacts: | Riga, 16 Dzirciema Street, block A 5th Floor, Room No 502, farmkk rsu[pnkts]lv, +371 67061544 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 8 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 16 | ||||
| Classes (count) | 8 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 16 | ||||
| Total Contact Hours | 32 | ||||||||
| Study course description | |||||||||
| Preliminary Knowledge: | Biology, pharmacology. | ||||||||
| Objective: | This course has been designed to introduce students to the basic biotechnology and various types of biopharmaceutical products, and to enable students to understand the design principles and quality assessment for biologic therapeutics. | ||||||||
| Topic Layout (Full-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Introduction in biopharmaceutics. | Lectures | 1.00 | auditorium | |||||
| 2 | Quality assessment for biopharmaceutics | Classes | 1.00 | laboratory | |||||
| 3 | Basis of biotechnology | Lectures | 1.00 | auditorium | |||||
| 4 | Gene analysis methods | Classes | 1.00 | laboratory | |||||
| 5 | Bioanalysis of biologics | Lectures | 1.00 | auditorium | |||||
| 6 | Protein analysis methods | Classes | 1.00 | laboratory | |||||
| 7 | Therapeutic proteins. Recombinant insulin. | Lectures | 1.00 | auditorium | |||||
| 8 | Bioassays | Classes | 1.00 | laboratory | |||||
| 9 | Monoclonal antibodies | Lectures | 1.00 | auditorium | |||||
| 10 | Monoclonal antibodies | Classes | 1.00 | laboratory | |||||
| 11 | RNA therapeutics | Lectures | 1.00 | auditorium | |||||
| 12 | Residual DNA Testing | Classes | 1.00 | laboratory | |||||
| 13 | Gene-based and cellular biologics | Lectures | 1.00 | auditorium | |||||
| 14 | Gene therapy | Classes | 1.00 | laboratory | |||||
| 15 | Biosimilars | Lectures | 1.00 | auditorium | |||||
| 16 | Presentation of the course work | Classes | 1.00 | laboratory | |||||
| Assessment | |||||||||
| Unaided Work: | Scientific literature review. Completion of the study course evaluation questionnaire. | ||||||||
| Assessment Criteria: | Analysis of scientific data. | ||||||||
| Final Examination (Full-Time): | Exam (Written) | ||||||||
| Final Examination (Part-Time): | |||||||||
| Learning Outcomes | |||||||||
| Knowledge: | Knowledge about basics of biotechnology, different types of biotherapeutics and their therapeutic areas. | ||||||||
| Skills: | To evaluate the quality of biological medicines, to apply basic analysis methods. | ||||||||
| Competencies: | To understand design principles for biologics and the biologics drug life-cycle. | ||||||||
| Bibliography | |||||||||
| No. | Reference | ||||||||
| Required Reading | |||||||||
| 1 | Zinātnisko publikāciju datu bāzes./Databases of scientific publications. | ||||||||
| Additional Reading | |||||||||
| 1 | FDA. Purple Book. Database of Licensed Biological Products | ||||||||
