| The development of pharmacological treatment of obesity in children : A European regulatory perspective. | |
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MedLine Citation:
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PMID: 21547648 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Childhood obesity is recognized by the World Health Organization as one of the most serious public health challenges of the 21st century. Current treatment recommendations consider the role of pharmacotherapy in the treatment of childhood obesity, as an adjunct to lifestyle modifications. This article focuses on key requirements for paediatric development of medicines for obesity in Europe with reference to the European Medicines Agency guideline and a review of Paediatric Investigation Plans (PIP) submitted for this condition, under Regulation (EC) No. 1901/2006 on medicines for paediatric use. To date the European Medicines Agency (EMA) received four paediatric investigation plans for childhood obesity. Issues encountered during the assessment of paediatric investigation plans were all related to the characteristics of the patient population, trial design, choice of endpoints, and safety aspects. Although the number of paediatric investigation plans submitted to the European Medicines Agency thus far is limited, current experience highlights the need for clinical trial protocols that are in line with the specific European guideline. Divergent approaches should be discussed with regulatory authorities before paediatric trials are initiated and included in paediatric investigation plans. |
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Authors:
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J Karres; P Tomasi; A Saint Raymond |
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Publication Detail:
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Type: JOURNAL ARTICLE |
Journal Detail:
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Title: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Volume: 54 ISSN: 1437-1588 ISO Abbreviation: - Publication Date: 2011 May |
Date Detail:
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Created Date: 2011-5-6 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101181368 Medline TA: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Country: - |
Other Details:
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Languages: ENG Pagination: 570-576 Citation Subset: - |
Affiliation:
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Human Medicines Special Areas, European Medicines Agency, 7 Westferry Circus, E14 4HB, Canary Wharf, London, UK, Janina.Karres@ema.europa.eu. |
Vernacular Title:
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Die Entwicklung von Medikamenten für die Behandlung von Adipositas bei Kindern : Eine europäisch-regulatorische Sichtweise. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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