Linked Life Data

12356096

Source:http://linkedlifedata.com/resource/pubmed/id/12356096

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
93
pubmed:dateCreated
2002-9-30
pubmed:abstractText
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth general principles that are relevant to all controlled trials and are especially pertinent to the major clinical trials intended to demonstrate drug (including biological drug) efficacy. The guidance describes the principal types of control groups and discusses their appropriateness in particular situations. The guidance is intended to assist sponsors and investigators in the choice of control groups for clinical trials.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
T
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0097-6326
pubmed:author
pubmed:issnType
Print
pubmed:day
14
pubmed:volume
66
pubmed:owner
HSR
pubmed:authorsComplete
Y
pubmed:pagination
24390-1
pubmed:dateRevised
2009-11-3
pubmed:meshHeading
pubmed:year
2001
pubmed:articleTitle
International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
pubmed:publicationType
Journal Article