By World Health Organization
The guide is an in depth handbook giving a step-by-step method of project the pharmacovigilance of antimalarials. it truly is meant to be a resource of sensible suggestion for pharmacovigilance centres. It presents info on spontaneous reporting of difficult drug reactions as a supplement to different WHO courses. furthermore, it presents info on the way to behavior cohort occasion tracking, that's a mode of lively defense surveillance amassing details on all hostile occasions happening after therapy. It additionally information tips to practice causality evaluate and sign identity, acceptable to either equipment of surveillance.
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Additional info for A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines
G. a food consumption survey performed for estimating “healthy nutrition” is used for estimating exposure to heavy metals). 5 Uncertainty in the determination of the statistical distribution used to represent distributed parameter values Probability distribution models can be used to represent frequency distributions of variability or uncertainty distributions. When the data set represents variability for a model parameter, there can be uncertainty in any non-parametric statistic associated with the empirical data.
However, quite often not all the model variables are considered in a formal uncertainty analysis. g. time–activity data, dietary food consumption data) are often used in predicting only the inherent variability in exposures of individuals within the study population. Principle 4 The presence or absence of moderate to strong dependencies between model inputs is to be discussed and appropriately accounted for in the analysis. In principle, the outputs from variability and uncertainty analysis are used to quantify the nature of the variability in the predicted distribution of the exposures and the uncertainties associated with different percentiles of the predicted population exposure or risk estimates.
For regulatory purposes, the level of the tiered approach is essential to describe the choice of data, whether defaults, upper-bound estimates or other single point estimates, or distributions have been used. This choice may govern the kind of uncertainty analysis. The definition of the scope and purpose of each exposure assessment provides the specifications for building the exposure scenario, which represents the real-life situation that is to be assessed and provides the boundary limits of the assessment.
A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines by World Health Organization