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

By World Health Organization

The instruction manual is an in depth handbook 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 presents info on spontaneous reporting of difficult drug reactions as a supplement to different WHO guides. moreover, it offers information on find out how to behavior cohort occasion tracking, that is a style of energetic protection surveillance accumulating details on all opposed occasions taking place after remedy. It additionally info the best way to practice causality review and sign identity, appropriate to either equipment of surveillance.

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

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The implications of a small, random and representative sample are that the confidence intervals estimated for statistics of interest, such as the mean, can be very wide. e. the sample standard deviation) and which statistic is of interest. For example, the sampling distribution of a mean value is asymptotically normal as the sample size increases. However, the sampling distribution for the variance is positively skewed. Examples of sample uncertainty: 1. 2. 3. 4. 5. g. n = 1000) is obtained at random and represents a specific stratum of a population of interest, such as a specific age and sex cohort.

Geographic applicability and seasonal applicability); microenvironments; population activities; sources of the released agent; exposure pathways; exposure events; exposure routes; and risk management measures. Incomplete and irrelevant specification of the above elements of the exposure scenario may be related to lack of knowledge, descriptive errors, aggregation errors, errors in professional judgement and incomplete analysis (USEPA, 1992). The following short descriptions represent examples that were primarily referred to as scenario uncertainties.

E. an estimated absorbed percentage of the total amount of the substance). 4 Model detail A model is a hypothesis regarding how a system works or responds to changes in its inputs. The development of a model involves decisions regarding what to include (or exclude) in the model and how much to aggregate the representation of processes that are included in the scope of the model. For example, a decision might be made to exclude a specific exposure pathway from a model because it is deemed to be of negligible impact to total exposures from 20 Part 1: Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment all pathways.

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