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MPharm Pharmacy / Course details
Year of entry: 2023
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Course unit details:
The Medicine (Year 3) - Drug Development Process 2
|Unit level||Level 3|
|Teaching period(s)||Full year|
|Available as a free choice unit?||No|
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.
|Unit title||Unit code||Requirement type||Description|
- 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.
Semester 1 exam: Pharmaceutics
2 hour written exam
Semester 2 exam: Drug disposition and Pharmacokinetics
2 hour written exam
|Simulation and Drug Development Workshops||20%||15|
N.B. In order to progress, student needs to pass each of the Pharmaceutics (semester 1) and Drug Disposition and Pharmacokinetics (semester 2) exams. In addition, students' combined Drug development and Simulation workshop marks must exceed 40%.
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 of all PHAR30100 workshops is compulsory for MPharm and BSc students. This applies to Pharmaceutics case studies workshops (semester 1), Simulation workshops (semester 1) and Drug Development Workshops (semesters 1 and 2). Attendance is compulsory regardless whether workshops are done in person or online.
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).
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 members associated with a particular Pharmaceutics topic (Pharmaceutics workshops).
David.Allison@manchester.ac.uk (Drug Development workshops).
- 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).
|Scheduled activity hours|
|Assessment written exam||4|
|Practical classes & workshops||36|
|Independent study hours|
|Aleksandra Galetin||Unit coordinator|