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A Practical Handbook on the Pharmacovigilance of by World Health Organization PDF

By World Health Organization

ISBN-10: 9241547499

ISBN-13: 9789241547499

The guide is an in depth guide giving a step-by-step method of project the pharmacovigilance of antimalarials. it really is meant to be a resource of functional recommendation for pharmacovigilance centres. It offers info on spontaneous reporting of difficult drug reactions as a supplement to different WHO courses. additionally, it offers information on easy methods to behavior cohort occasion tracking, that is a mode of energetic defense surveillance gathering details on all adversarial occasions taking place after remedy. It additionally information how one can practice causality review and sign id, appropriate to either tools of surveillance.

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Extra info for A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

Example text

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. The combined sensitivity and uncertainty are also used in a two-dimensional probabilistic exposure or dose assessment, in order to determine either the uncertainty about exposure (or 34 Part 1: Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment dose) at a given percentile or the uncertainty about percentile for a given exposure (or dose) level.

Zhao & Frey, 2004). Structural uncertainties in a distribution can be represented by empirical distributions or a mixture of a discrete and parametric distribution, as described previously. Unless there is a need to partition the distribution into zero and non-zero components, failure to account for the frequency of zero values can lead to overestimation of the mean of the overall distribution. Example of uncertainty in the choice of distribution for estimation of exposure to cadmium from iceberg lettuce consumption: The estimated distributions of cadmium exposure from iceberg lettuce consumption and their statistics are displayed in Figure 3, using different distributions of cadmium concentration.

G. g. overlooking an important exposure pathway). Scenario uncertainty characterization may include a description of the information used for the scenario characterization (scenario definition). This includes a description of the purpose of the exposure analysis. 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.

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A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines by World Health Organization

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