World Health Organization's A Practical Handbook on the Pharmacovigilance of PDF

By World Health Organization

ISBN-10: 9241547499

ISBN-13: 9789241547499

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 useful suggestion for pharmacovigilance centres. It offers details on spontaneous reporting of difficult drug reactions as a supplement to different WHO guides. furthermore, it presents information on the way to behavior cohort occasion tracking, that is a style of energetic safeguard surveillance gathering info on all opposed occasions taking place after remedy. It additionally info tips on how to practice causality overview and sign identity, acceptable to either tools of surveillance.

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

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3. 4. 5. Failure to account for possible correlation between the frequency of use of a consumer product by a consumer and the amount used per use. Expression of a linear relation by taking an exponential term. Using a constant emission rate to describe the evaporation of a chemical from a matrix without taking into account that the rate of evaporation will depend on the chemical concentration in both air and the matrix. In simulating lifelong exposure to a persistent pollutant, the body weight of a simulated individual at different stages of life will be correlated.

These are often derived from existing measured or modelled values and in some cases based on expert judgements. g. g. Monte Carlo simulation) parameter and input value uncertainties, as appropriate. When few parameters are involved in the exposure calculations, analytical methods may be in order. g. Monte Carlo, Bayesian) techniques for sensitivity and uncertainty analysis. g. with one-dimensional Monte Carlo analysis). Consequently, in such instances, it is not possible to readily distinguish the relative contribution of inherent variability in the exposure or risk factors from knowledge-based uncertainties to total assessment uncertainties.

There are, as mentioned, overlaps, and even expert opinions may 16 Part 1: Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment deviate. Identification of the sources of scenario uncertainty is a matter of interpretation and depends on the clarity with which the scope and purpose of the assessment are given. It is not possible to quantify all sources of uncertainty. Therefore, expression of uncertainty, variability or both in exposure estimates may be qualitative or quantitative, but uncertainty should be quantified to the extent that is scientifically achievable.

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


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