Study-Unit Description

Study-Unit Description


TITLE Approaches to Analysis of Drugs and Metabolites

UM LEVEL 02 - Years 2, 3 in Modular Undergraduate Course



DEPARTMENT Clinical Pharmacology and Therapeutics

DESCRIPTION This study-unit will address the techniques and approaches used for the analysis of common drugs. It will cover the correct approaches and timings for drug sampling for diverse objectives such as pharmacokinetic studies, therapeutic drug monitoring and identification of drug abuse, and students will learn the techniques and instrumentation used for such analysis. The study-unit will also cover drug sampling and analysis methodologies used in animal models, with a focus on the pre-clinical phases of drug development.

Study-unit Aims:

The study-unit aims to enable students to critically evaluate the principles, applications and limitations of instrumental analytical techniques of drugs and their metabolites in body fluids, and in vitro molecular pharmacology experiments. The study-unit will also cover in vitro assays for biological activity, e.g. antibiotic sensitivity and IC50 testing. It will provide students with the knowledge to select and implement appropriate analytical techniques to solve a given analytical problem.

Learning Outcomes:

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

- Describe and evaluate instrumental methods for analysis of common therapeutic drugs, drugs of abuse and metabolites in various body fluids;
- Discuss appropriate methods and timings of body fluid sampling techniques for drug analysis, in human patients as well as animal models;
- List and describe drug analysis approaches in animal models, including sampling techniques, as well as real-time direct measurement of small molecules in awake, ambulatory animals;
- Evaluate special issues related to analysis of drugs abused in sports, including the WADA list, intentional detection-avoidance techniques such as drug masking etc.

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

- Propose the appropriate drug analysis approach to various clinical situations, e.g. therapeutic drug monitoring, drug abuse in sports and illicit street drug use;
- Identify appropriate drug analysis approaches appropriate for micro-volume in vitro pharmacology research experiments;
- Assess situations and propose rationale, where metabolite analysis, in addition to, or instead of parent drug analysis is required.

Main Text/s and any supplementary readings:

Main text:

- Rahman H. Applications of Analytical Techniques / Methods in Drug Analysis. 2012. Lap Lambert Academic Publishing.

Supplementary readings:

- Moffat AC, Osselton MD, Widdop B. Clarke's Analysis of Drugs and Poisons. 4th Ed. 2011. Pharmaceutical Press.


- Molecular pharmacology. Published by the American Society for Pharmacology and Experimental Therapeutics.
- British Journal of Pharmacology. Published by the British Pharmacological Society.
- British Journal of Clinical Pharmacology. Published by the British Pharmacological Society.

STUDY-UNIT TYPE Lecture and Independent Study

Assessment Component/s Assessment Due Sept. Asst Session Weighting
Examination (2 Hours) SEM1 Yes 100%

LECTURER/S Melchior Cini
Janet Mifsud
Godwin Sammut
Sonia Waiczies Chetcuti


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.