PM3PCOL3-Clinical Pharmacology & Toxicology

Module Provider: Pharmacy
Number of credits: 30 [15 ECTS credits]
Level:6
Terms in which taught: Autumn / Spring / Summer module
Pre-requisites: PM2PCOL1 Molecular Drug Targets and PM2PCOL2 Drug Design and Delivery and PM2PCOL3 Mathematical Modelling for Pharmacology
Non-modular pre-requisites:
Co-requisites: PM3PCOL1 Research Project and PM3PCOL2 Societal Impact of Pharmacology
Modules excluded:
Current from: 2023/4

Module Convenor: Dr Darius Widera
Email: d.widera@reading.ac.uk

Type of module:

Summary module description:

This module expands from core principles of drug action and molecular drug target modules in Part 1 and Part 2 to focus on clinical aspects of drug discovery and translation from preclinical studies to the human situation and associated potential human toxicology. The module focuses on molecular drug targets in the peripheral and central nervous system, the musculoskeletal system and in cancer and pain. It will also provide advanced knowledge on drug pharmacokinetics, drug development and using higher risk drugs (e.g. for cancer, pain), or novel therapies (e.g. gene therapy).  In addition, students will develop a knowledge of so-called ‘lifestyle’ drugs and the effects misuse of these drugs can have on human physiology. The module will also expand the knowledge on drugs used in healthcare and how organisations such as the National Institute for Health and Care Excellence (NICE) provide guidelines for the use of medicines. The module will also consider the basic principles of toxicology, poisons and the treatment of poisoning from animals, microorganisms and plants, how chemicals adversely affect embryonic development, and the principles behind the use of pharmacology/toxicology in the development of new medicines. The module will be taught with the aid of lectures, case studies, practicals and workshops which will provide students with opportunities to take part to an ‘experimental’ clinical trial, handle and analyse the data obtained as well as being able to design their own study. 

Aims:

The module aims to provide further insight into clinical aspects of drug discovery and translation from preclinical studies to the human situation. The module aims to:

• introduce students to the molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, and in cancer and pain


• further knowledge and understanding of how the body handles drugs and what factors affect pharmacokinetic processes


• provide knowledge and understanding on how drugs are discovered and developed as medicines and thus how trials are designed, research data generated, handled, analysed and interpreted. How information from clinical trials and drug development is used to guide the use of medicines for patients in clinical practice.


• to provide students with opportunities to design and take part to an ‘experimental’ clinical trial, generate, handle, analyse and interpret data obtained.


• to familiarize students with current concepts of mechanisms by which cells are killed by toxic chemicals with particular emphasis on drugs.


• to develop in students an understanding of the main defence mechanisms that cells possess to protect them against chemical toxicity; to develop in students' knowledge and understanding in toxicology in relation to drug development.

Assessable learning outcomes:

Students will be able to:

• Describe molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, musculoskeletal system and cancer and pain


• Discuss how drugs are discovered and developed as medicines and thus how trials including those using higher risk drugs (e.g. for cancer, pain) and novel therapies (e.g. gene therapy) are designed, research data generated, handled, analysed and interpreted.


• Describe how drugs are tested in healthy adults, neonates, pregnant women and elderly


• Describe how information from clinical trials and drug development is used to guide the use of medicines for patients in clinical practice.) 


• Understand clinical trial design, generate, handle, analyse and interpret the data obtained.


• Show understanding of how drugs and medicines used in healthcare are recommended by organisations such as the National Institute for Health and Care Excellence (NICE


• Communicate effectively within a team and communicate findings to a wider audience.

Additional outcomes:

Working in small groups during laboratory practical classes and workshops students will develop self-learning, time management & communication skills. Students will learn how communicate effectively within a team and communicate findings to a wider audience. Students will also improve team-working skills, such as leadership, motivating and working with others, and contribute to identifying the learning and development needs of team members through coaching and feedback.

Outline content:

• Molecular drug targets in the peripheral and central nervous system, the musculoskeletal system, and cancer and pain


• Factors including age, pregnancy, diseases and genetics that affect drugs’ pharmacokinetic, effects and side effects.


• Neonatology & Paediatrics: Diseases affecting the newborn/prematurely born; drug use and pharmaceutical care considerations in neonates and children; how drugs are tested in children and pregnant women.


• Main multi-organ disorders of old age; co-morbidities in elderly and multi-organ disease: 


• Cancer: Detecting and staging metastatic cancer; routes of metastasis; resistance to chemo- and radiotherapy; emerging anti-cancer drug discovery programmes, advances in personalised medicines, the localized delivery of anti-cancer agents, anti-angiogenic agents


• Novel trial designs, trials using high risk drugs (e.g. for cancer, pain), trials using novel therapies (e.g. nanomedicine, cancer vaccines, gene therapy)


• Describe the effects of drugs of abuse on human physiology


• Genetics, responses to drugs and personalised medicine


• Hot topics in clinical pharmacology and advances in therapeutics


• Types of clinical trials and the processes need to deliver them


• Clinical trial design, data handling collection and interpretation


• Processes and regulation required to get a drug to market and how data about drugs is processed and used to decide how to treat patients in healthcare


• Outline the basic principles of toxicology with reference to specific organs (e.g. kidney)


• Describe common adverse drug reactions


• Describe the cellular effects of chemical poisons and approaches in the treatment of poisoning.


• State how animal, microorganism and plant toxins act on humans.


• Outline the key stages in clinical trials and the importance of pharmacology in these stages


• Demonstrate an understanding of the relationship between safety toxicology studies and drug development

Brief description of teaching and learning methods:

The course content will be provided through a mixture of formal lectures, practical sessions, supported by tutorial sessions. Attendance to all teaching sessions is required and poor attendance will be recorded in the student’s personal file.

Contact hours:

	Autumn	Spring	Summer
Lectures	15	15
Tutorials	5	5	5
Practicals classes and workshops		8
Guided independent study:
Wider reading (independent)	10	10
Wider reading (directed)	15
Exam revision/preparation	10	30	10
Preparation of practical report		45
Revision and preparation	10	30	10
Group study tasks		20
Essay preparation		10
Reflection		32	5
Total hours by term	65	205	30
Total hours for module	300

Summative Assessment Methods:

Method	Percentage
Written exam	60
Set exercise	40

Summative assessment- Examinations:

There will be a three-hour final examination.

The examination for this module will require a narrowly defined time window and is likely to be held in a dedicated exam venue.

Summative assessment- Coursework and in-class tests:

2 set exercises (20% each), 3h each

Formative assessment methods:

Formative assessment and associated feedback form a large proportion of the module, with students being provided with workshops, tutorials and online assessments to prepare for the final examination. Formative assessment is provided through compulsory small group tutorials and workshops, instructor-, self-, and peer-led assessment and feedback.

Penalties for late submission:

The Support Centres will apply the following penalties for work submitted late:

• where the piece of work is submitted after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for that piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of five working days;
• where the piece of work is submitted more than five working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

The University policy statement on penalties for late submission can be found at: https://www.reading.ac.uk/cqsd/-/media/project/functions/cqsd/documents/cqsd-old-site-documents/penaltiesforlatesubmission.pdf
You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Assessment requirements for a pass:

Students must obtain an overall module mark of 40%.

Reassessment arrangements:

Reassessment arrangements are in accordance with University policy. Reassessment of the written examination is held during the University administered re-examination period in August. Failed coursework may be reassessed by an alternative piece of work, before or during the August examination period. Final year students are not eligible to resit this module unless they have failed their degree programme overall.

Additional Costs (specified where applicable):

1) Required text books: 

2) Specialist equipment or materials: 

3) Specialist clothing, footwear or headgear: 

4) Printing and binding: 

5) Computers and devices with a particular specification: 

6) Travel, accommodation and subsistence: 

Last updated: 30 March 2023