The COVID Positive Pathway: a collaboration between public health agencies, primary care, and metropolitan hospitals in Melbourne.

Objectives: To assess the capacity of the COVID Positive Pathway, a collaborative model of care involving the Victorian public health unit, hospital services, primary care, community organisations, and the North Western Melbourne Primary Health Network, to support people with coronavirus disease 2019 (COVID-19) isolating at home.

Design, Setting, Participants: Cohort study of adults in northwest Melbourne with COVID-19, 3 August - 31 December 2020.

Main Outcome Measures: Demographic and clinical characteristics, and social and welfare needs of people cared for in the Pathway, by care tier level.

Evolving paradigms in pharmacovigilance.

All medicines have adverse effects as well as benefits. The aim of pharmacovigilance is to protect public health by monitoring medicines to identify and evaluate issues and ensure that the overall benefits outweigh the potential risks. The tools and processes used in pharmacovigilance are continually evolving.

Design and analysis of accelerated degradation tests for the stability of biological standards I. Properties of maximum likelihood estimators.

The accelerated degradation test is commonly used to predict the stability of a biological standard during long-term storage at low temperatures. The analysis of complicated by the fact that the standard generally defines its own unit of activity, so only relative rates of degradation at different temperatures can be observed. A series of Monte Carlo simulation studies is described which has been carried out to investigate the accuracy and precision of estimates based on the statistical method and are of use in assessing the extent to which the size and design of the accelerated degradation test influence the precision of the estimate of the low temperature degradation rate.

Design and analysis of accelerated degradation tests for the stability of biological standards II. A flexible computer program for data analysis.

The accelerated degradation test is commonly used to predict the stability of a biological standard during long-term storage at low temperature. A flexible computer program is described which has been written to analyse degradation test results by the method of maximum likelihood. In addition to predicting the degradation rate at low temperature, the program furnishes estimates of statistical precision and it carried out a test of goodness of fit of the data to the assumed Arrhenius equation model.

Standardization of Factor VIII-III. Establishment of a stable reference plasma for Factor VIII-related activities.

An international collaborative study has been carried out to establish a reference plasma for Factor VIII-related activities. The freeze-dried reference plasma, coded 80/511, was assayed against fresh normal plasma, local standards and another freeze-dried plasma. There was good agreement between laboratories for the comparison of the two freeze-dried plasmas, but wide variation in the comparison of plasma 80/511 with fresh normal plasma and local standards, indicating the differences in Factor VIII content of local pooled plasmas.