Clearing 2022

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MPharm Pharmacy

Year of entry: 2022

Course unit details:
The Medicine (Year 3) - Drug Development Process 2

Course unit fact file
Unit code PHAR30100
Credit rating 30
Unit level Level 3
Teaching period(s) Full year
Offered by
Available as a free choice unit? No

Overview

Provide a good understanding of pharmacokinetics of small molecules. Demonstrate application of scientific principles in the development of different drug formulations. Integrate knowledge of disease states, different routes of administration and pharmacokinetics. Develop problem solving and data analysis skills. Work effectively within team and develop communication skills through Pharmacokinetic Simulation and Drug Development workshops.

 

Pre/co-requisites

Unit title Unit code Requirement type Description
PHAR10100 Pre-Requisite Compulsory
PHAR10200 Pre-Requisite Compulsory
PHAR10300 Pre-Requisite Compulsory
PHAR10400 Pre-Requisite Compulsory
PHAR20100 Pre-Requisite Compulsory
PHAR20200 Pre-Requisite Compulsory
PHAR20300 Pre-Requisite Compulsory
PHAR20400 Pre-Requisite Compulsory
PHAR10500 Pre-Requisite Compulsory
PHAR20500 Pre-Requisite Compulsory

Aims

Pharmaceutics: To provide an understanding of the control of microorganisms in pharmaceutical products and in the manufacturing and handling environments, through physical and chemical agencies. To understand which biological factors in the GI tract influence dissolution, solubility and permeability, and the effect of gastric retention and intestinal transit times.

To develop understanding of transdermal drug delivery systems and apply it to existing and new products in clinical practice. To equip students with an understanding of the various devices and formulations used for inhaled drug delivery and their limitations, appreciate how their properties and behaviour can be quantified and assessed. To understand the importance of therapeutic monoclonal antibodies, their production, mode of action and why they may lead to an immune response. To understand formulation stability, the factors governing aggregation and how this can be controlled using excipients. For all lectures students should be able to apply knowledge to case studies.

Drug Disposition and Pharmacokinetics: To provide an understanding of absorption, distribution, metabolism and excretion processes and properties of metabolites. To understand metabolic and transporter-mediated drug-drug interactions and consequences on drug efficacy and safety.

To develop core knowledge of pharmacokinetics of a drug following single and multiple dose administration, intravenous and oral and to apply such knowledge to the rational design of dosage regimens in different disease states.

Simulation workshops: Integration of knowledge and scientific pharmacokinetic principles with clinical practice. Simulation of virtual clinical trials/patients.

Drug Development workshop: Introduction to the concepts of product safety, formulation, strategy, clinical trials, licensing, registration and marketing

Assessment methods

End of semester 1:

2h written exam, Pharmaceutics unit  - 30% of the Medicine PHAR30100 mark

End of semester 2:

2h written exam, Drug Disposition and Pharmacokinetics unit  - 50% of the Medicine PHAR30100 mark

Drug Development Workshop – 10% (group mark)

Simulation workshops – 10% (group mark)

Assessment

Weighting

Equivalent Credits

Semester 1 exam – Pharmaceutics

 30%

9

Semester 2 exam – Drug disposition and pharmacokinetics

 50%

15

Combined Simulation and Drug Development Workshops

 20%

6

N.B. In order to progress, student needs to pass each individual exam, i.e., Pharmaceutics (sem 1) and Drug Disposition and Pharmacokinetics (sem 2) exams. In addition, combined Drug development and Simulation workshop mark needs to exceed 40%.

Formative assessment: Formative assessments will be done in weeks 4, 9 and 12 in semester 1; all details will be provided on Blackboard. Answers will subsequently be uploaded on Blackboard and/or discussed in interactive feedback/Q&A sessions.

Attendance requirements

Attendance of all PHAR30100 workshops is compulsory for MPharm and BSc students. This applies to Pharmaceutics case studies workshops (sem 1), Simulation workshops (sem 1) and Drug Development Workshops (sem 1 and 2). Attendance is compulsory regardless whether workshops are done in person or online.

Feedback methods

Students are encouraged to discuss questions with academic staff and peers after lectures/workshops, in dedicated interactive Q&A sessions or to contact academic staff by email.

Feedback is also given in all the workshops and scheduled Revision sessions (detailed in the unit timetables for sem 1 and sem 2).

Contact details:

Aleksandra.Galetin@manchester.ac.uk  

(Unit lead; Specific questions related to material covered in Drug disposition & Pharmacokinetics component and Simulation workshops)

Alain.Pluen@manchester.ac.uk  and  individual staff member associated with a particular Pharmaceutics topic (Pharmaceutics workshops)

 

David.Allison@manchester.ac.uk   (Drug Development workshops)

Recommended reading

FASTtrack Pharmaceutics: Dosage Form & Design; Chapter 8, Respiratory Dosage Forms. David S. Jones;

Pharmaceutical Press, ISBN 978 0 85711 078 7.

Aulton’s Pharmaceutics 6th Edition ,ME Aulton and K Taylor, Chapters 19 and 43.

Biologics: review papers will be added on Blackboard.

Principles of Human Physiology (any edition) Germann & Stanfield

Clinical Pharmacokinetics: concepts and applications. Rowland M and Tozer T. 4th edition. Philadelphia, London: Lippincott Williams & Wilkins, 2010 (Chapters 3-11, and 15; relevant individual chapters will be stated in lectures)

 

Study hours

Scheduled activity hours
Assessment written exam 4
Lectures 56
Practical classes & workshops 36
Independent study hours
Independent study 190

Teaching staff

Staff member Role
Aleksandra Galetin Unit coordinator

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