| CODE | PHR1610 | ||||||||
| TITLE | Pharmaceutical Regulatory Sciences 1 | ||||||||
| UM LEVEL | 01 - Year 1 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 5 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | Overview of drug development stages. Drug discovery and drug design: - A goal drug - Methods of drug discovery - A lead and candidate compound - Pharmacology studies - Drug metabolism studies - Toxicology studies - Pharmaceutical preformulation Regulatory systems and the pharmaceutical market: - Effective regulation and the pharmaceutical industry - Placing medicines on the market - Risk-benefit assessment of medicinal products - Rational use issues Study-unit Aims: - To identify the steps in developing a new drug. - To focus on the discovery and new drug development stages. - To expose the student to the importance of the preformulation phase in the pharmaceutical industry. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Understand the process of drug development. - Develop familiarity with the process of drug discovery and drug design. - Describe preformulation of pharmaceutical dosage forms. 2. Skills: By the end of the study-unit the student will be able to: - Identify the stages of drug development. - Relate historical aspects of drug development. - Compare and understand preformulation tests. Main Text/s and any supplementary readings: - British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency. British Pharmacopoeia. London: The Stationery Office; 2011. ISBN 9780113228492. - Gibson M, editor. Pharmaceutical preformulation and formulation: A practical guide from candidate drug selection to commercial dosage form. Florida: CRC Press; 2001. - Rick NG. Drugs: From discovery to approval. New Jersey: John Wiley & Sons; 2009. - Allen LV, Popovich NG, Ansel H. Ansel's pharmaceutical dosage forms and drug delivery systems. Baltimore: Lippincott Williams & Wilkins; 2005. |
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| STUDY-UNIT TYPE | Lecture | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Valentina Tabone Borg Decelis Danika Agius Lilian 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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