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

By World Health Organization

ISBN-10: 9241547499

ISBN-13: 9789241547499

The guide is a close handbook giving a step-by-step method of project the pharmacovigilance of antimalarials. it's meant to be a resource of sensible recommendation for pharmacovigilance centres. It offers info on spontaneous reporting of inauspicious drug reactions as a supplement to different WHO courses. furthermore, it presents info on tips on how to behavior cohort occasion tracking, that is a mode of lively security surveillance accumulating details on all hostile occasions taking place after therapy. It additionally info the best way to practice causality evaluation and sign id, acceptable to either equipment of surveillance.

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

Example text

The 1996 Food Quality Protection Act in the United States advocated the use of a 10-fold safety factor to address the special sensitivity of infants and young children to pesticides when a screening-level analysis of exposures is performed using the Standard Operating Procedures (SOPs) of the USEPA’s Office of Pesticides. g. anything that might justify a smaller uncertainty factor than the default one) and to take account of any additional (higher-tier) data. Tier 1 analysis is intended to examine how likely it is that, and by how much, the exposure or risk levels of concern may be exceeded.

Uncertainty is introduced by questions as to how representative the extrapolated data are for the situation in which they are used. Examples of extrapolation uncertainty: 1. 2. 3. The extrapolation of an estimation made for adults to children would imply a high degree of uncertainty. Children are not little adults. Normally, exposures are referred to body weight; however, the mechanisms that govern the physiological mechanisms for absorption, distribution and elimination (including metabolism) of substances in the body are linearly related not to body weight but to body surface (BgVV, 2001).

Common to all approaches are the following working steps: x x specification of the purpose and scope of the assessment; and building of the assessment scenario. In addition, the quantitative approaches include: x x x x a description of the selected assessment approach, including monitoring and/or modelling steps, which specify the parameters needed in the assessment; selection of data and specification of any assumptions; execution of calculations; and documentation, interpretation and presentation of results.

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


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