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Promoting Safety of Medicines for Children.

Monitoring 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 licence - in terms of formulation, indi...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: WHO
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Geneva : World Health Organization, 2007.
Temas:
Acceso en línea:Texto completo

MARC

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245 1 0 |a Promoting Safety of Medicines for Children. 
260 |a Geneva :  |b World Health Organization,  |c 2007. 
300 |a 1 online resource (64 pages) 
336 |a text  |b txt  |2 rdacontent 
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520 |a Monitoring 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 licence - in terms of formulation, indications, contraindications or age - constitutes off-label and off-licence use and these are a major area of concern."Promoting Safety of Medicines for Children" is intended to improve awareness of medicine safety issues among those with an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in the paediatric populations. This publication will be of interest to all health care professionals, medicine regulatory authorities, pharmacovigilance centres, academia, the pharmaceutical industry, and policy-makers. 
505 0 |a Introduction -- 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. 
504 |a Includes bibliographical references. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Drug monitoring. 
650 0 |a Drugs  |x Safety measures. 
650 0 |a Drugs  |x Toxicology. 
650 0 |a Pediatric pharmacology. 
650 0 |a Pharmacovigilance. 
650 0 |a Drugs  |x Side effects  |x Reporting. 
650 2 |a Drug Monitoring 
650 2 |a Pharmacovigilance 
650 2 |a Product Surveillance, Postmarketing 
650 6 |a Pharmacovigilance. 
650 6 |a Médicaments  |x Sécurité  |x Mesures. 
650 6 |a Médicaments  |x Toxicologie. 
650 6 |a Pharmacologie pédiatrique. 
650 7 |a Pharmacovigilance  |2 fast 
650 7 |a Drugs  |x Side effects  |x Reporting  |2 fast 
650 7 |a Drug monitoring  |2 fast 
650 7 |a Drugs  |x Safety measures  |2 fast 
650 7 |a Drugs  |x Toxicology  |2 fast 
650 7 |a Pediatric pharmacology  |2 fast 
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