18762934

Source:http://linkedlifedata.com/resource/pubmed/id/18762934

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Predicate	Object
rdf:type	pubmed:Citation
lifeskim:mentions	umls-concept:C0003191, umls-concept:C0008976, umls-concept:C1549649, umls-concept:C2349209
pubmed:issue	1
pubmed:dateCreated	2008-12-18
pubmed:abstractText	This paper assesses the design of clinical studies used in the process of regulatory approval, focusing on how add-on studies affect regulatory decisions.
pubmed:language	eng
pubmed:journal	http://linkedlifedata.com/resource/pubmed/journal/1256165
pubmed:citationSubset	IM
pubmed:chemical	http://linkedlifedata.com/resource/pubmed/chemical/Antirheumatic Agents
pubmed:status	MEDLINE
pubmed:month	Jan
pubmed:issn	1432-1041
pubmed:author	pubmed-author:Bertele'VittorioV, pubmed-author:GarattiniSilvioS, pubmed-author:OttolenghiLauraL
pubmed:issnType	Electronic
pubmed:volume	65
pubmed:owner	NLM
pubmed:authorsComplete	Y
pubmed:pagination	33-41
pubmed:meshHeading	pubmed-meshheading:18762934-Antirheumatic Agents, pubmed-meshheading:18762934-Clinical Trials as Topic, pubmed-meshheading:18762934-Drug Approval, pubmed-meshheading:18762934-Drug Therapy, Combination, pubmed-meshheading:18762934-Europe, pubmed-meshheading:18762934-Government Regulation, pubmed-meshheading:18762934-Humans, pubmed-meshheading:18762934-Practice Guidelines as Topic, pubmed-meshheading:18762934-Research Design, pubmed-meshheading:18762934-Treatment Outcome
pubmed:year	2009
pubmed:articleTitle	Limits of add-on trials: antirheumatic drugs.
pubmed:affiliation	Laboratory of Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy.
pubmed:publicationType	Journal Article, Review