| CODE | PHR5033 | ||||||||||||
| TITLE | Qualified Person Requirements: Applied Physiology and Biochemistry | ||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||
| MQF LEVEL | 7 | ||||||||||||
| ECTS CREDITS | 5 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | This study-unit tackles the applied, physiology, biochemistry, toxicology and pharmacology principles in the area of pharmaceutical medicinal products development required to be covered by candidates aspiring to seek approval to practice as a Qualified Person in the pharmaceutical industry. From a gap analysis to an identification of the areas required, the study unit addresses the compulsory issues required to practice as a Qualified Person. Study-unit Aims: To present applied aspects of physiology, biochemistry, toxicology and pharmacology considered in medicinal product development as related to activities undertaken by Qualified Persons as stipulated in the EU Directive 2001/83/EC. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - identify physiology pathways that are relevant to formulation development of medicines; - describe biochemical pathways that affect handling of drugs by the body; - evaluate and relate important toxicological aspects to physiological processes identify the important concepts in pharmacology as they apply to physiological and biological processes. 2. Skills By the end of the study-unit the student will be able to: - apply principles of applied physiology and biochemistry to the formulation development of medicinal products; - extrapolate aspects of applied physiology and biochemistry to pharmaceutical processes relevant to the pharmaceutical industry; - apply prinicples of toxicology to help understand interactions of xenobiotics with biological systems; - apply the pharmacokinetic principles of liberation, absorption, distribution, metabolism and elimination (LADME) to drug action. Main Text/s and any supplementary readings: - Brunton LL, Knollmann BC, Hilal-Dandan R. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 13th ed. USA:McGraw-Hill Education; 2017. - Hodgson E. A textbook of modern toxicology. 4th ed. USA: Wiley; 2011. - Kumar V, Abbas A, Aster J. Robbins & Cotran Pathologic Basis of Disease. 9th ed. Elsevier; 2014. - Ritter JM, Flower R, Henderson G, Rang HP. Rang & Dale's Pharmacology,. 2019. 9th Eed. Churchill Livingstone.; 2019. - Rowland M, Tozer TM. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications,. 2011. 4th Revised Ed. Lippincott Williams and Wilkins;. 2011. - Stine KE, Brown TM. Principles of Toxicology 3rd edn. USA: CRC Press; 2015. - Woodbury CP. Biochemistry for the Pharmaceutical Sciences. USA: Jones & Bartlett Learning; 2012. |
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| STUDY-UNIT TYPE | Lecture | ||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Ruth Agius Annalise Goggi Janis Vella Francesca Wirth |
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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 2024/5. It may be subject to change in subsequent years. |
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