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A Practical Handbook on the Pharmacovigilance of by World Health Organization

By World Health Organization

The instruction manual is an in depth guide 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 offers details on spontaneous reporting of inauspicious drug reactions as a supplement to different WHO courses. furthermore, it presents information on the right way to behavior cohort occasion tracking, that is a mode of lively safeguard surveillance amassing info on all opposed occasions taking place after therapy. It additionally information the best way to practice causality review and sign id, acceptable to either tools of surveillance.

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

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This might, in some cases, provide a sufficient basis to reach a risk management decision at Tier 1; if not, it would form the basis for performing Tier 2 uncertainty analysis. Examples of Tier 1 uncertainty analysis: 1. g. ranges of pollutant concentrations, differences in exposure durations, inhalation rates, body weights) that are used to predict high-end exposures of individuals. 2. Identifying the key sources of uncertainties in food consumption rates and dietary residue data during a dietary exposure and risk analysis, and subsequently examining their respective influence on model predictions.

Identifying the key sources of uncertainties in food consumption rates and dietary residue data during a dietary exposure and risk analysis, and subsequently examining their respective influence on model predictions. 3. g. uncertainties associated with surface residue concentrations, frequency of hand contact with contaminated surfaces, pesticide transfer efficiency from different types of surfaces to the hand or body). 3 Tier 2 (deterministic) uncertainty analysis In a higher-tier analysis, semiquantitative or quantitative sensitivity analysis, interval or perhaps factorial and probability-bound analyses are considered.

Examples of Tier 1 uncertainty analysis: 1. g. ranges of pollutant concentrations, differences in exposure durations, inhalation rates, body weights) that are used to predict high-end exposures of individuals. 2. Identifying the key sources of uncertainties in food consumption rates and dietary residue data during a dietary exposure and risk analysis, and subsequently examining their respective influence on model predictions. 3. g. uncertainties associated with surface residue concentrations, frequency of hand contact with contaminated surfaces, pesticide transfer efficiency from different types of surfaces to the hand or body).

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