Document Detail


Sources of bias in signals of pharmaceutical safety in pregnancy.
MedLine Citation:
PMID:  21134336     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
Every year scores of new pharmaceuticals enter the market, almost never with human fetal safety data. Such data typically accumulate during the first years of clinical use, in the form of case reports, case series, prospective and retrospective cohorts and case control studies. All of these methods suffer from serious sources of bias, often leading to alarming signals of teratogenicity that are later found to be false. This review highlights major sources of bias, including the bias against the null hypothesis in its different forms, ascertainment and recall bias, in fetal exposure to pharmaceutical molecules.
Authors:
Gideon Koren; Sheri Nickel
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Publication Detail:
Type:  Journal Article     Date:  2010-12-01
Journal Detail:
Title:  Clinical and investigative medicine. Médecine clinique et experimentale     Volume:  33     ISSN:  1488-2353     ISO Abbreviation:  Clin Invest Med     Publication Date:  2010  
Date Detail:
Created Date:  2010-12-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7804071     Medline TA:  Clin Invest Med     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  E349-55     Citation Subset:  IM    
Affiliation:
Hospital for Sick Children, 555 University Avenue, Toronto, Ontario. gideon.koren@sickkids.ca
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