| CODE | CPH3905 | ||||||||
| TITLE | In Vitro and in Vivo Models and Translational Research in Pharmacology and Toxicology | ||||||||
| UM LEVEL | 03 - Years 2, 3, 4 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 6 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Clinical Pharmacology and Therapeutics | ||||||||
| DESCRIPTION | Translational pharmacology research mainly comprises the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. Therefore this area spans and links the processes of laboratory and pre-clinical research to their direct application for human therapeutics. This approach is often also referred to as "bench to bedside" and also incorporates issues related to cost-effectiveness of prevention and treatment, and any other factors needed to validate and bring pre-clinical research outcomes to their clinical applications. This study-unit therefore focuses on pharmacological research models and how the data generated by such models can be eventually further researched and developed for therapeutic applications, and introduced into the clinical environment. Study-unit Aims: - Expose students to the principles and importance of translational research; - Present translational research as a planned continuum of different stages; - Provide examples of translational research pipelines; - Explain factors that may hinder translational research; - Emphasize the roles of good practice in different stages of translational research; - Describe the role of ethics in translational research; - Emphasize the importance of interdisciplinary roles in translational research; Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - Describe various models used in drug research, and explain their advantages and disadvantages; - Describe study designs used in translational research; - Identify features that characterize translational research ecosystems: translational stages, developmental phase, clinical application, data types and collection methods, unit of analysis, etc.; - Define the fundamental concepts of precision, accuracy, validity, causality, and types of associations; - Identify the steps from defining a target population to selecting a study sample; - Propose a translational research pipeline for a hypothetical drug; - Describe systematic reviews and meta-analysis and how these may contribute to a translational research pipeline. 2. Skills By the end of the study-unit the student will be able to: - Describe different in vitro and in vivo models used in pharmacology research; - Discuss the relevance of translational research to pharmacology; - Discuss the stages of hypothesis development, population and study sample selection, defining study measures, and power and sample size calculations; - Describe observational and experimental study designs; - Propose basic research areas which may be candidates for translational research; - Identify translational research requirements, and prepare a theoretical plan for a named drug; - Describe biostatistical approaches in clinical translational research. Main Text/s and any supplementary readings: Main text: - Vohora D (Ed), Singh G (Editor). Pharmaceutical Medicine and Translational Clinical Research 1st Edition. 2017. Academic Press. Additional material will be provided directly to students. 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 | ||||||||
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| LECTURER/S | Analisse Cassar Jessica Debattista Melissa Marie Formosa Lucienne Gatt Laura Grech Janet Mifsud Vanessa Petroni (Co-ord.) Brandon Charles Seychell Nathan Vella |
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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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