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010   $a9786611307479
010   $a92-4-068233-3
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100   $a20081023d2007      uy         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aPromoting safety of medicines for children /$fWorld Health Organization
205   $a1st ed.
210   $aGeneva $cWorld Health Organization$d2007
215   $a1 online resource (64 p.)
300   $aDescription based upon print version of record.
311   $a92-4-156343-5 
320   $aIncludes bibliographical references.
327   $aIntroduction -- Current situation -- The essential role of safety monitoring in the life-cycle of a medicine -- Medication errors -- Primary responsibility of stakeholders -- Guidance : measures to be taken -- Measures to be taken by WHO.
330   $aMonitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.
606   $aDrugs$xSafety measures
606   $aDrugs$xToxicology
606   $aDrug monitoring
606   $aPediatric pharmacology
615  0$aDrugs$xSafety measures.
615  0$aDrugs$xToxicology.
615  0$aDrug monitoring.
615  0$aPediatric pharmacology.
676   $a615.58083
676   $a615.58083615.542
712 02$aWorld Health Organization.
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910813919403321
996   $aPromoting safety of medicines for children$94090781
997   $aUNINA