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| Module Availability |
| Semester Two |
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| Assessment Pattern |
Coursework - 30%
Examination - 70% |
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| Module Overview |
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| Prerequisites/Co-requisites |
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| Module Aims |
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To create an awareness of the scope of regulatory toxicology in relation to industrial chemicals, food additives and contaminants, pharmaceuticals and consumer products
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To provide a sound understanding of the principles underlying toxicity testing and risk assessment, including concepts of the NOEL, ADI, MTD, OEL
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To provide an appreciation of the methodology and regulatory requirements for the conduct of toxicity tests to investigate acute, sub-chronic, chronic and reproductive toxicity, and special tests for genotoxicity, carcinogenicity and immunotoxicity
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To study the mechanisms of target tissue, cell and organelle toxicity
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To study both acute and chronic toxicity
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To illustrate mechanisms of toxicity and testing schema using specific examples
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| Learning Outcomes |
On successful completion of this module you should:-
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Understand the concepts of hazard characterisation and risk assessment
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Appreciate the extensive series of toxicological tests in vitro and in vivo necessary to evaluate potential toxicity, assess risk and assess safety in use of food additives, pharmaceuticals, chemicals in consumer products and industrial chemicals
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Understand the limitations of animals as surrogates for humans in toxicological assessment and safety assurance, and how interspecies and interindividual differences in sensitivity are accommodated
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Recognise common themes in mechanisms of toxicity
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Understand the basic concepts underlying the development of toxicity
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Understand the basic principles of action of a number of toxins that act upon organs central to exposure (skin, lung), metabolism (liver) and excretion (kidney) of xenobiotics
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| Module Content |
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Lecture No:
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Lecturer
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Topic
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1
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NJP
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Introduction: Module overview, assessment criteria and basic concepts
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2
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SCP
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Regulatory framework - authorities and requirements for different categories of chemicals
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3
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SCP
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Basics of experimental toxicology - GLP and the Animal (Scientific Procedures) Act
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4 - 5
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SCP
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Basics of experimental toxicology - Requirements for a protocol
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6 – 7
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LM
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Basic mechanisms of Toxicity: Oxidative stress
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8 – 9
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KES
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Basic mechanisms of Toxicity: Receptor-mediated toxicity
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10 – 11
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NJP
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Basic mechanisms of Toxicity: Biologics and nanoparticles
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12
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CI
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In Vitro Genotoxicity testing - 1
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13
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CI
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In Vitro Genotoxicity testing - 2
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14
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SCP
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Toxicity testing - acute
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15
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SCP
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Toxicity testing - sub-chronic and chronic
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16
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SCP
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Toxicity testing - carcinogenicity
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17
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SCP
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Toxicity testing - reproductive
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18
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SCP
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Drug development cycle including paediatric drugs
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19
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SCP
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Drug development cycle - relation to clinical studies
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20
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NJP
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Pharmacokinetic studies in Drug Development
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21
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SCP
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Case Study - Pharmaceuticals - including biotechnology products
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22 – 23
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KES
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Case Study: Pulmonary toxins
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24 – 25
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KES
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Case Study: Liver toxins: mechanisms
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26 – 27
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SCP
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Case Study: Liver and kidney toxins: pathology
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28 – 29
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NJP
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Case Study: Kidney toxins: mechanisms
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30
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NJP
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Module Review and Tutorial
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| Methods of Teaching/Learning |
| Lectures, tutorial. |
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| Selected Texts/Journals |
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Recommended Books:
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Advanced Text in Molecular Toxicology (2003) N. Plant: BIOS
Introduction to Toxicology, 3rd edition, (2002) J A Timbrell, London: Taylor & Francis
A Guide To Practical Toxicology, 2nd edition (2008), Adam Wooley: Taylor & Francis
Principles of Toxicology Testing (2008) FA Barille : CRC Press
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| Last Updated |
| 18 April 2011 |
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