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

By World Health Organization

The instruction manual is a close handbook giving a step-by-step method of project the pharmacovigilance of antimalarials. it's meant to be a resource of useful recommendation for pharmacovigilance centres. It presents info on spontaneous reporting of difficult drug reactions as a supplement to different WHO courses. additionally, it offers information on tips to behavior cohort occasion tracking, that's a style of lively defense surveillance amassing info on all hostile occasions happening after remedy. It additionally info tips on how to 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

Furthermore, it is suggested that within this exercise, 31 Harmonization Project Document No. 6 Tier 0 analysis may be done just once, but not repeated for every individual assessment. Even though Tier 0 assessments are practical to conduct, they are not suited for addressing problems that require a realistic identification of key factors and exposure conditions contributing to assessment outcomes and uncertainties. Higher-tier assessments are often needed to answer such questions. Examples of Tier 0 analysis: 1.

2. x Nine experts were asked to rank substances (1–5 rankings) in a list according to their toxicological relevance. All rankings were presented (G. Heinemeyer, personal communication, 2005). Multiple experts were asked to assess the uncertainty in concentration–response functions associated with human exposure to particulate matter. The experts were selected and their judgements encoded according to a formal protocol. , 2004). Default data: Default values are reference values recommended for use for specific purposes—for instance, in screening-level assessments.

These uncertainties should be confronted as an integral part of the process, rather than being limited to the final stage. Principle 1 Uncertainty analysis should be an integral part of exposure assessment. e. as a screening-level assessment or as a detailed, probabilistic assessment). The level of detail with which the uncertainty is analysed will vary accordingly and should, as a rule, be consistent with the level of detail of the exposure assessment. The objective of an uncertainty analysis is to determine differences in the output of the assessment due to the combined uncertainties in the inputs and to identify and characterize key sources of uncertainty.

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