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PHCY259 Quality of Medicines

Determinants of quality, compendial standards, quality assurance, analysis of medicines, pharmaceutical data and its interpretation, counterfeit medicines, quality of herbal and complementary medicines, expiry dating, generic medicines and interpretation of bioequivalence data, regulatory control of quality of medicines.

Paper title Quality of Medicines
Paper code PHCY259
Subject Pharmacy
EFTS 0.0950
Points 12 points
Teaching period Second Semester
Domestic Tuition Fees (NZD) $745.37
International Tuition Fees (NZD) $3,467.50

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Limited to
Teaching staff
Dr Allan Gamble, Dr Arlene McDowell, Mr David Schmierer and Professor Stephen Duffull
Paper Structure
23 Lectures
4 Tutorials
3 Laboratories
1 Workshop
Teaching Arrangements
Lectures, laboratories, tutorials, CAL laboratories and workshops
Watson, D. G., (2005) Pharmaceutical Analysis: a textbook for pharmacy students and pharmaceutical chemists, 2nd edn, Elsevier/Churchill Livingston.
Donnelly, Jr, R. A., (2007) The Complete Idiot's Guide to Statistics, 2nd edn, Penguin USA.
Kirkwood, B.R., Sterne J.A.C., (2003) Essential Medical Statistics, 2nd edn, Blackwell Science.
Graduate Attributes Emphasised
Lifelong learning, Communication, Critical thinking, Cultural understanding, Ethics, Information literacy, Research.
View more information about Otago's graduate attributes.
Learning Outcomes
By the end of this paper you should be able to:
  • Define and interpret what factors determine the quality of a medicine
  • Describe and interpret pharmacopoeial standards for medicines
  • Describe and interpret some methods for analysis of medicines
  • Describe and interpret the role of quality assurance in assuring the quality of medicines, generally and in the community pharmacy
  • Describe and interpret quality of medicine issues in relation to herbal and complementary medicines
  • Name the regulatory authority responsible for quality of medicines in New Zealand and describe its role
  • Present data in clear and appropriate ways and carry out a limited number of statistical analyses of data
  • Determine whether a medicine meets a specified standard of quality
  • Predict whether a medicine is of appropriate quality by analysing a report containing quantitative data about the medicine

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Second Semester

Teaching method
This paper is taught On Campus
Learning management system


Stream Days Times Weeks
A1 Monday 09:00-09:50 33
Monday 10:00-10:50 32-33
B1 Tuesday 09:00-09:50 40
Tuesday 10:00-10:50 28-29, 32
Tuesday 11:00-11:50 30, 32, 36, 40
Tuesday 12:00-12:50 33
C1 Wednesday 09:00-09:50 32, 34, 38
D1 Thursday 10:00-10:50 28-30
Thursday 11:00-11:50 37
E1 Friday 09:00-09:50 40
Friday 10:00-10:50 34
G1 Tuesday 11:00-11:50 34


Stream Days Times Weeks
E1 Friday 09:00-09:50 36-37
Friday 10:00-10:50 32, 38