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Guidelines for submitting adverse event reports for publication
Pharmacoepidemiology and drug safety, 2007-05, Vol.16 (5), p.581-587
Kelly, William N.
Arellano, Felix M.
Barnes, Joanne
Bergman, Ulf
Edwards, I. Ralph
Fernandez, Alina M.
Freedman, Stephen B.
Goldsmith, David I.
Huang, Kui
Jones, Judith K.
McLeay, Rachel
Moore, Nicholas
Stather, Rosie H.
Trenque, Thierry
Troutman, William G.
van Puijenbroek, Eugene
Williams, Frank
Wise, Robert P.
2007
Details
Autor(en) / Beteiligte
Kelly, William N.
Arellano, Felix M.
Barnes, Joanne
Bergman, Ulf
Edwards, I. Ralph
Fernandez, Alina M.
Freedman, Stephen B.
Goldsmith, David I.
Huang, Kui
Jones, Judith K.
McLeay, Rachel
Moore, Nicholas
Stather, Rosie H.
Trenque, Thierry
Troutman, William G.
van Puijenbroek, Eugene
Williams, Frank
Wise, Robert P.
Titel
Guidelines for submitting adverse event reports for publication
Ist Teil von
Pharmacoepidemiology and drug safety, 2007-05, Vol.16 (5), p.581-587
Ort / Verlag
Chichester, UK: John Wiley & Sons, Ltd
Erscheinungsjahr
2007
Link zum Volltext
Quelle
Wiley Online Library Journals Frontfile Complete
Beschreibungen/Notizen
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause‐effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events. Copyright © 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.
Sprache
Englisch
Identifikatoren
ISSN: 1053-8569
eISSN: 1099-1557
DOI: 10.1002/pds.1399
Titel-ID: cdi_swepub_primary_oai_prod_swepub_kib_ki_se_115501990
Format
–
Schlagworte
Adverse Drug Reaction Reporting Systems - standards
,
Aged
,
Chemical and Drug Induced Liver Injury
,
Diagnosis, Differential
,
Drug-Related Side Effects and Adverse Reactions - chemically induced
,
Drug-Related Side Effects and Adverse Reactions - diagnosis
,
Humans
,
Liver Diseases - diagnosis
,
Male
,
Medicin och hälsovetenskap
,
Pharmaceutical Preparations - administration & dosage
,
Publishing - standards
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