MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Radiopharmacy Advanced

Unit code PHAR61940
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Semester 2
Offered by Pharmacy
Available as a free choice unit? No

Overview

  • Regulations controlling transport of radioactive materials in the UK and the means taken to comply with these regulations.
  • The mechanisms by which commonly used radiopharmaceuticals localise in their target tissues.
  • Problems which might arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate.
  • Interactions both desired and undesirable between radiopharmaceuticals and other medications.
  • Sources of reference information on all aspects of radiopharmaceuticals.
  • Cyclotrons and the production of Positron Emission Tomography (PET) radiopharmaceuticals.
  • The general principles of PET imaging.
  • The organisation of a PET radiopharmacy.
  • PET radiopharmaceuticals and their production.
  • Clinical indications for the use of PET.
  • Routine procedures used in hospital radiopharmacy management.
  • The organisational and financial aspects of a commercial radiopharmacy.
  • The relative advantages of commercial and non-commercial systems.
  • QC parameters which determine the quality of radiopharmaceuticals.
  • The analytical methods by which QC parameters are measured.
  • The principles of radionuclide generators, their design and operation including the 99Mo/99mTc generator system other generators in routine use.
  • Radiation hygiene and safe working in radiopharmaceutical preparation.
  • Automation in radiopharmaceutical preparation.
  • Physical and chemical properties of therapeutic radiopharmaceuticals.
  • Therapeutic radiopharmaceutical products approved for general use in nuclear medicine together with their clinical applications.
  • The functions of the different cell types routinely labelled in nuclear medicine.
  • Cell labelling procedures.
  • Clinical indications for cell labelling.

Aims

The aim of the Radiopharmacy Advanced unit is to build on the background knowledge provided in the Radiopharmacy unit (Introduction to Clinical Pharmaceutical Science 2). Students will gain an in-depth knowledge of how to operate at a much higher level within a radiopharmacy, dealing with complex issues that may arise. They will also learn of novel drug development and imaging modalities.

Teaching and learning methods

  • One-week teaching block including workshops, practicals and site visits.
  • E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

 

Knowledge and understanding

  • Discuss the role of the Clinical Scientist in Radiopharmacy in the diagnosis and treatment of disease using radiopharmaceuticals, including the contribution to patient management and patient centred care
  • Discuss the regulations controlling transport of radioactive materials in the UK and describe the means taken to comply with these regulations.
  • Explain the mechanisms by which commonly used radiopharmaceuticals localise in their target tissues.
  • Describe those problems which might arise during the preparation and clinical use of radiopharmaceuticals and know how to identify and solve them where appropriate.
  • Describe the possibilities for interactions both desired and undesirable between radiopharmaceuticals and other medications.
  • Access and evaluate sources of reference information on all aspects of radiopharmaceuticals.
  • Describe the general principles of Positron Emission Tomography (PET) imaging and the organisation of a PET radiopharmacy and list the products most commonly used therein together with their clinical indications.
  • Describe the types of procedures routinely employed in hospital radiopharmacy management.
  • Explain the Quality Control parameters which determine the quality of radiopharmaceuticals.
  • Describe the analytical methods by which these parameters are measured.
  • Discuss the significance of the development of radionuclide generators for Nuclear Medicine, and the principles of their design and operation, describe the Molybdenum-99/Technetium-99m generator system and give examples of other generators in routine use.
  • Discuss the importance of radiation hygiene and safe working in radiopharmaceutical preparation.
  • Discuss the need for automation in radiopharmaceutical preparation and the possible ways in which this might be achieved.
  • Discuss the physical and chemical properties required of a therapeutic radiopharmaceutical and list the products approved for general use in Nuclear Medicine together with their clinical applications.
  • Describe the functions of the different cell types routinely labelled in nuclear medicine, outline the most significant points in the labelling procedures used and list the most common clinical indications for these radiopharmaceuticals.

Intellectual skills

  • Interpret stability data to determine the shelf life of the product.
  • Critically evaluate a range of microbiological and physical monitoring methods.
  • Critically appraise the impact of the radiopharmaceutical production process on the quality of clinical outcomes.

Practical skills

  • Work safely in the radiation environment.
  • Perform a range of radiopharmaceuticals.
  • Perform radiochemical purity testing on a range of radiopharmaceuticals and interpret results.
  • Interpret and analyse monitoring data and diagnose problems.
  • Assist with clean room commissioning and routine monitoring.

Transferable skills and personal qualities

  • Effectively utilise a range of information sources.
  • Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills.
  • Demonstrate effective communication skills (verbal and written).
  • Be able to set priorities and link these with effective time management.
  • Critically evaluate their personal performance both as an individual and within a team.
  • Demonstrate skills in working collegiately and effectively with others as a member of a team.
  • Show appreciation of the way in which legislation, standards and quality management interface with normal working life.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Scheduled activity hours
Lectures 22
Independent study hours
Independent study 128

Teaching staff

Staff member Role
Beverley Ellis Unit coordinator

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