University of Malta

Study-Unit Description
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TITLE Pharmacotoxicology

LEVEL 05 - Postgraduate Modular Diploma or Degree Course


DEPARTMENT Clinical Pharmacology and Therapeutics

DESCRIPTION This study-unit will present current topics in pharmacotoxicology as they apply and relate to the pharmaceutical industry.

Through this study-unit candidates will thus obtain a basic knowledge of toxicology which they would be able to apply in practice. The study-unit will thus cover basic principles in:
• drug structure/pharmacological/toxicology action relationships;
• drug pharmacokinetics: absorption, distribution, metabolism and elimination of drugs;
• principal routes of drug administration;
• basic principles of toxicology and toxicokinetics;
• chemical, physical and microbiological factors that could potentially affect content uniformity, stability and bioavailability of drugs in the manufacturing process;
• the EU REACH directive.

Study-unit Aims:

Through this study-unit the student will obtain an understanding of the fundamental principles involved in the actions and uses of medicines in clinical practice, in order to judge their significance for the manufacture of these pharmaceutical products.

This proposed study-unit will thus aim to provide an overview of:
- General aspects of chemical structure/pharmacological action relationships in drugs;
- Give an overview of key therapeutic drug classifications with examples of disease states and their treatment with medicinal products;
- Biotransformation and kinetics: absorption, distribution, metabolism and elimination of drugs and its role on the pharmacodynamic effect;
- Biopharmaceutical aspects of dosage form design;
- Principles and assessment of toxicology;
- Mechanisms of toxicology;
- Production of sterile and non-sterile products and associated environmental controls;
- Interpretation of microbiological data;
- Safety, health and environment with respect to pharmaceutical drug manufacture;
- Pharmacovigilance related to quality monitoring;
- General implications of clinical knowledge of drugs upon facility design, plant segregation/isolation, cleaning verification and production scheduling;
- The regulatory requirements and REACH directive.

Students will thus develop a critical, rational attitude to role of toxiciology in drug manufacturing.

Learning Outcomes:

1. Knowledge & Understanding:
By the end of the study-unit the student will be able to:

- Apply basic principles in pharmacology and pharmacokinetics in the manufacture of pharmaceutical products;
- Describe the basic mechanisms of drug action and drug toxicology;
- Understand the role of risk assessment in pharmaceutical production;
- Outline the role of microbiological contamination in pharmaceutical production;
- Understand environmental risks of pharmaceutical production.

2. Skills:
By the end of the study-unit the student will be able to:

- Apply knowledge of the toxicological properties of a pharmaceutical product and its effects when assessing whether a particular molecule should be introduced into their facility;
- outline the risks in terms of toxic effects for carry over of one substance into the batches of another substance;
- list the risks associated with handling particular molecules;
- assess risks associated with the accidental release of drug products and manufacturing related effluents into the envirnoment;
- demonstrate an understanding of the sources and types of micro-organisms as related to pharmaceutical production.

Main Text/s and any supplementary readings:

Main Texts:

- Griffin JP. Textbook of Pharmaceutical Medicine. 6th edition Wiley-Blackwell; 2009
- International Programme on Chemical Safety Joint Project with OECD on the Harmonisation of Hazard/Risk Assessment Terminology. Descriptions of selected key generic terms used in chemical hazard/risk assessment.
- Wallace Hayes (ed) Principles and Methods of Toxicology. 5th edition CRC; 2008. (available in Library)
- WHO. Descriptors of selected key generic terms used on chemical hazard/risk assessment. 2006.

Other Texts:

- Boelsterli Urs A. Mechanistic toxicology : The molecular basis of how chemicals disrupt biological targets. 2nd edition CRC; 2007.
- Barile FA. Pharmacotoxicology of Chemical and Biological Terrorism Am J Pharm Ed 2004; 68 (3) 1-9.
- European Chemicals Agency.The REACH directive Frequently Asked Questions on REAC by Industry. 2008.
- OECD. The OECD Environmental Risk Assessment Toolkit: Tools for Environmental Risk Assessment and Management. 2010.,3343,en_2649_34373_44909430_1_1_1_1,00.html
- RPSGB. Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry Study Guide. May 2006.
- WHO. World Health Organization Guidelines for the Public Health Management of Chemical Incidents and Emergencies. 2007.
- WHO. IPCS Risk Assessment terminology. 2004.

Various related scientific journals which are available online through library services.

ADDITIONAL NOTES Pre-requisite Qualifications: Bachelor Degree in Life Sciences, with a Chemistry and Biology component.

This study-unit has been accepted by Malta Enterprise as a recognised certification and qualification under the Get Qualified Scheme. Please click here for further information.

STUDY-UNIT TYPE Lecture & Independent Online Learning

Assessment Component/s Resit Availability Weighting
Assignment Yes 50%
Examination (2 Hours) Yes 50%

LECTURER/S Maria A. Cordina
Anne Marie Dimech
Anthony Fenech
Godfrey Grech
Suzanne Magri Demajo
Anna McElhatton
Janet Mifsud (Co-ord.)
Charles Scerri
Patricia Vella Bonanno
Mark Zammit

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 study-unit description above applies to the academic year 2017/8, if study-unit is available during this academic year, and may be subject to change in subsequent years.

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