VISTAMDS-CPH5500-SEM2-AE-2024-5-F - L-Università ta' Malta

Course Title

CPH5500 - Pharmacotoxicology

MQF Level

Duration and Credits

Semester 2

6 ECTS

Mode of Study

Part-Time Evening

Information for International applicants

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This micro-credential is exclusively being offered to PharOS MT Ltd.

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 pharmacology and 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 and the principles of therapeutics related to the life cycle of a medicine;
overview of drug classes and function;
basic and clinical principles of toxicology relevant to medicinal products;
chemical, physical and microbiological factors that could potentially affect content uniformity, stability and bioavailability of drugs in the manufacturing process;
concepts in risk assessment and regulatory aspects of toxicology.

Main Reading List

Raj GM and Raveendran R (Eds) Introduction to Basics of Pharmacology and Toxicology. 2019. Springer.
Olson K, Anderson I, Benowitz N, Blanc P, Clark R, Kearney T, Kim-Katz S, Wu A. Poisoning and Drug Overdose. 7th Ed. 2017. McGraw-Hill Education.
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. https://www.who.int/publications/i/item/9241562676
Wallace Hayes (ed) Principles and Methods of Toxicology. 5th edition CRC; 2008.
WHO. Descriptors of selected key generic terms used on chemical hazard/risk assessment. 2024. https://www.oecd-ilibrary.org/environment/descriptions-of-selected-key-generic-terms-used-in-chemical-hazard-risk-assessment_9789264079120-en

Supplementary Reading List

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. 2024. https://echa.europa.eu/support/qas
OECD. The OECD Environmental Risk Assessment Toolkit: Tools for Environmental Risk Assessment and Management. 2010. https://one.oecd.org/document/ENV/JM/HA(2010)14/en/pdf
RPSGB. Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry Study Guide. 2024 https://www.rpharms.com/development/education-training/training/qualified-persons
WHO. World Health Organization Guidelines for the Public Health Management of Chemical Incidents and Emergencies. 2009 https://www.who.int/publications/i/item/9789241598149
Various related scientific journals which are available online through library services.

Study-unit Aims

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

This proposed study-unit will thus aim to:

Provide an overview of the general aspects of chemical structure/pharmacological action relationships of drugs;
Review key therapeutic drug classifications with examples of disease states and their treatment with medicinal products;
Biotransformation and kinetic: absorption, distribution, metabolism and elimination of drugs and its role on the pharmacodynamic effect;
Review biopharmaceutical aspects of dosage form design;
Describe principles, assessment and mechanisms of toxicology;
Explain safety, health and environment with respect to pharmaceutical drug manufacture;
Describe risk assessment and the regulatory requirements of pharmaceutical drug manufacture.

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

Learning Outcomes: Knowledge and 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;
Discuss approaches to minimize drug toxicity events, and to manage them if they occur;
Understand the role of risk assessment in pharmaceutical production;
Understand environmental risks of pharmaceutical production.

Learning Outcomes: Skills

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

Discuss the general therapeutic and adverse pharmacological actions associated with different drug classes;
Promote approaches to minimize drug toxicity;
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;
Assess risks associated with the use and accidental release of drug products and manufacturing related effluents into the environment.

Non EU Applicants:

No fees apply

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Micro-credentials offer the possibility of providing flexible learning pathways to respond to evolving needs and new developments, thus enabling students to tailor their studies to their needs. Micro-credentials may be combined or transferred into larger credentials, such as certificates, diplomas and degrees, provided that the relevant programme requirements are met. Applicants wishing to transfer micro-credentials to a programme of study are encouraged to seek the advice of the relevant academic entity.