Document Detail


Epidemiological approaches to safety investigations.
MedLine Citation:
PMID:  16713135     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This paper considers the different approaches to post-authorisation safety monitoring of veterinary medicinal products that is essential to ensure confidence in their safety. Most safety testing is undertaken prior to granting of a marketing authorisation and is generally on a small scale. Field trials are usually much larger, but still involve relatively low numbers of animals compared to the number to which authorised products are administered. Safety testing is generally aimed at detecting common events; the numbers of animals used in the tests are too small for detection of all but the most common reactions. The efficiency of the tests depends on the frequency and severity of the adverse reaction and the ability to associate the adverse event with the product. The latter is affected by the period of time between administration and the event, as well as by its underlying frequency. Adverse reaction surveillance is critical in monitoring the safety of a marketed product. Most is entirely passive and so reporting rates are likely to underestimate true incidence. It is relatively efficient for rare, serious adverse effects and for those with a low underlying frequency in the population, but it is less useful when there is long period between administration and the event, or where the event has a relatively high underlying frequency. Greater emphasis should be placed on active surveillance after production registration. Detailed epidemiological investigations, including cohort, case control and cross-sectional designs, offer the only approaches that provide more information on the association between a product and events that have a high underlying frequency in the population or where there is a long period between administration and the adverse event. The relative merits of different approaches are discussed, with particular reference to our recently published study of the temporal association between canine vaccination and non-specific signs of ill health and plans to undertake studies of associations with feline injection site sarcoma. Emphasis is placed on the need for clearly stated hypotheses and the consideration of equivalence, rather than significance testing when considering safety studies.
Authors:
J L N Wood; V J Adams
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Publication Detail:
Type:  Journal Article; Review     Date:  2006-04-18
Journal Detail:
Title:  Veterinary microbiology     Volume:  117     ISSN:  0378-1135     ISO Abbreviation:  Vet. Microbiol.     Publication Date:  2006 Oct 
Date Detail:
Created Date:  2006-09-12     Completed Date:  2006-11-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7705469     Medline TA:  Vet Microbiol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  66-70     Citation Subset:  IM    
Affiliation:
Cambridge Infectious Diseases Consortium, University of Cambridge, Department of Veterinary Medicine, Madingley Road, Cambridge CB3 0ES, UK. vicki.adams@aht.org.uk
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems*
Animals
Databases, Factual
Product Surveillance, Postmarketing*
Safety
Time Factors
Vaccines / adverse effects*
Chemical
Reg. No./Substance:
0/Vaccines

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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