| CODE | CPH2904 | ||||||||||||
| TITLE | Biological Drugs, Vaccines, Gene Therapy and Pharmacological Biotechnology | ||||||||||||
| UM LEVEL | 02 - Years 2, 3 in Modular Undergraduate Course | ||||||||||||
| MQF LEVEL | 5 | ||||||||||||
| ECTS CREDITS | 4 | ||||||||||||
| DEPARTMENT | Clinical Pharmacology and Therapeutics | ||||||||||||
| DESCRIPTION | This study-unit will provide a comprehensive overview of biologics, including pharmacokinetics and pharmacodynamics, pharmacoeconomics, regulatory aspects, manufacturing and delivery consideration, nomenclature and issues related to biosimilars. The types of vaccines, their development and use will also be addressed. The historical and current status of gene therapy approaches will be discussed, together with recent developments in this area. Study-unit Aims: This study-unit aims to equip students with knowledge on the very rapidly evolving area of biotherapeutics. Students will learn the pharmacology of therapeutic proteins, the diseases they target, their manufacture and their benefits and risks especially when compared to conventional drug molecules. The pharmacological applications of molecular biology to disease prevention and management will be emphasized. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - Illustrate the pharmacology of various biotherapeutic agents; - Identify and describe the manufacturing processes of biotherapeutic agents; - Illustrate specialized administration routes associated with biotherapeutic agents; - Discuss safety issues associated with these drugs; - Describe the molecular and clinical pharmacology of these drugs. 2. Skills By the end of the study-unit the student will be able to: - Apply the knowledge gained to practical clinical and molecular pharmacology research scenarios related to the drugs addressed in this study-unit; - Compare and contrast the benefits and risks of biologics with other drugs having similar indications; - Theoretically evaluate the risks and beneftis associated with particular gene therapy vectors; - Assess the theoretical benefits and risks associated with different types of vaccines. Main Text/s and any supplementary readings: Main text: - Ritter JM, Flower RJ, Henderson G, Loke YK, MacEwan D, Rang HP. Rang & Dale's Pharmacology. 9th Ed. 2019. Elsevier. - Katzung B and Trevor A. Basic and Clinical Pharmacology. 15th Ed. 2020 McGraw-Hill Education. Supplementary readings: - Satoskar RS, Rege NN, Bhandarkar SD. Pharmacology and Pharmacotherapeutics. 2015. Elsevier. - Brunton L, Knollmann B, Hilal-Dandan R.Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Ed. 2017. McGraw-Hill Education. Journals: - Molecular pharmacology. Published by the American Society for Pharmacology and Experimental Therapeutics. - British Journal of Pharmacology. Published by the British Pharmacological Society. - British Journal of Clinical Pharmacology. Published by the British Pharmacological Society. |
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| STUDY-UNIT TYPE | Lecture and Independent Study | ||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Analisse Cassar Jessica Debattista Victoria Farrugia Sant'Angelo Anthony Fenech Janet Mifsud David Saliba Pierre Schembri Wismayer |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2023/4. It may be subject to change in subsequent years. |
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