PM3PCOL3-Clinical Pharmacology & Toxicology

Module Provider: Pharmacy
Number of credits: 30 [15 ECTS credits]
Level:6
Terms in which taught: Spring term module
Pre-requisites:
Non-modular pre-requisites:
Co-requisites:
Modules excluded:
Current from: 2020/1

Module Convenor: Prof Gary Stephens

Email: g.j.stephens@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 muscloskeletal system and cancer. It will also provide advanced knowledge on drug development and using higher risk drugs (e.g. for cancer), or novel therapies (e.g. gene therapy). 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. 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 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 aimed to assess responses to anaesthetic creams, handle and analyse the data obtained as well as design their own study. The module will also expand the knowledge on drugs used in healthcare and how they are regulated and how organisations such as the National Institute for Health and Care Excellence (NICE) influences the use of medicines.

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, the endocrine system and cancer

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


• Provide knowledge and understandingÌý on how drugs are discovered and developed as medicines and thus how trial 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.


• Provide knowledge and understandingÌý on how drugs and medicines used in healthcare are regulated


• To provide students with opportunities to design novel ‘experimental’ drugs evaluatingÌýÌý pharmacological, chemical, and formulation properties of an active pharmaceutical ingredient


• 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 deep understanding in toxicology in relation to drug development and ability to apply, critically evaluate and interpret this knowledge to solve complex problems.

Assessable learning outcomes:

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, the endocrine system and cancer

• Further knowledge and understanding of how the body handles drugs and what factors affect pharm acokinetic processes;


• Provide knowledge and understandingÌý on how drugs are discovered and developed as medicines and thus how trial 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.


• Provide knowledge and understandingÌý on how drugs and medicines used in healthcare are regulated


• To prov ide students with opportunities to design novel ‘experimental’ drugs evaluatingÌýÌý pharmacological, chemical, and formulation properties of an active pharmaceutical ingredient


• 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 deep understanding in toxicology in relation to drug development and ability to apply, critically evaluate and interpret this knowledge to solve complex problems.

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 muscloskeletal system, the endocrine system; musculoskeletal system and cancer


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


• Hot topics in clinical pharmacology and advances in therapeutics


• Medicines use in Pregnancy & Breastfeeding


• Neonatology & Paediatrics:&n bsp;Paediatrics and Neonatal care: Diseases affecting the newborn/prematurely born; drug use and pharmaceutical care considerations in neonates and children


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


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


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


• 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


• Describe the effects of cannabis on human physiology


• Describe the effects of alcohol on human physiology


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


• How drugs are tested in children and pregnant women.


• Clinical trial design, data handling collection and interpretation


• Genetics, responses to drugs and personalised medicine


• 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


• Research and write about a topic appropriate to the study of human toxicology

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:

Ìý	Autumn	Spring	Summer
Lectures		30
Tutorials		2
Practicals classes and workshops		8
Guided independent study:	Ìý	Ìý	Ìý
Ìý Ìý Wider reading (independent)		50
Ìý Ìý Exam revision/preparation		50
Ìý Ìý Revision and preparation		60
Ìý Ìý Group study tasks		20
Ìý Ìý Essay preparation		40
Ìý Ìý Reflection		40
Ìý	Ìý	Ìý	Ìý
Total hours by term	0		0
Ìý	Ìý	Ìý	Ìý
Total hours for module	300

Summative Assessment Methods:

Method	Percentage
Written exam	70
Set exercise	30

Summative assessment- Examinations:

There will be a three-hour final examination.

Summative assessment- Coursework and in-class tests:

Pain practical and personalized medicine practical

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 Module Convenor 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[1] (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:
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% and obtain at least 40% in the final examination.

Reassessment arrangements:

Reassessment is by examination in August and will be by written examination. Students are normally permitted one further attempt at any failed assessments. Failed coursework may be reassessed by an alternative piece of work, before or during the August examination period.Ìý

Additional Costs (specified where applicable):

Last updated: 20 October 2020