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This subject teaches fundamentals of probability and statistics, clinical trial processes and regulations of therapeutic goods and specialised health care environments to Master of Engineering (Biomedical) students.
Foundations of probability: independence, conditional probability, Bayes’ rule; Random variables: cumulative distributions, probability mass and probability density functions, expectation and variance, functions of a random variable, important distributions and their properties and uses; Sums, inequalities and limit theorems: Basic statistical concepts: confidence intervals, hypothesis testing, significance levels, correlation, analysis of variance; Decision testing: maximum likelihood, maximum a posteriori, minimum cost and Neyman-Pearson rules, basic minimum mean-square error estimation, regression.
Risk management and international and Australian regulatory guidelines for electrical, chemical, biological and administrative health care processes, in particular medical devices: regulations, classifications and standards; familiarisation with specialised clinical/laboratory environmental control and containment guidelines; ethical standards and sponsor responsibilities.
Clinical trials: Design and analysis of experiments; Clinical trials and ethical consent; Principles of drug development: Global regulation and harmonisation of format of processes, decisions and good clinical practices; Institutional structures, product information and guidelines: clinical trials notification schemes, human ethics, chemical, synthesis and property drug information, and drug guidelines; Drug regulation in Australia.
Intended learning outcomes
INTENDED LEARNING OUTCOMES (ILOs)
Having completed this subject it is expected that the student be able to:
- Demonstrate an understanding of the axioms of probability, random variables, Bayes’ rule, and the ability to calculate and interpret probabilities, probability densities, means, variances and covariances
- Demonstrate the ability to fit probability models to data by both estimating and testing hypotheses about model parameters
- Apply standard statistical procedures using a statistical computing package
- Describe the appropriate standards used in the design and maintenance of biomedical devices and the appropriate schedules in the distribution of therapeutic agents
- Describe the regulations that are required to place a new medical device or a therapeutic agent into a clinical trial and then market
- Describe important processes of experimental design in pre-clinical and clinical trials
- Describe the therapeutic device/agents post-market evaluation and incident reporting schemes
- Discuss the ethics, standards and regulations applicable to the development of therapeutic devices and/or agents in Australia and overseas.
On completion of this subject, students should have developed the following generic skills:
- Understanding of social, cultural, global, and environmental responsibilities and the need to employ principles of sustainable development
- Ability to communicate effectively, with the engineering team and with the community at large
- Ability to manage information and documentation
- Understanding of professional and ethical responsibilities, and commitment to them
- Ability to function effectively as an individual and in multidisciplinary and multicultural teams, as a team leader or manager as well as an effective team member.
Last updated: 18 December 2020