Linked Life Data

21142907

Source:http://linkedlifedata.com/resource/pubmed/id/21142907

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
12
pubmed:dateCreated
2010-12-14
pubmed:abstractText
Discussion and output from the US FDA and the pharmaceutical industry from the Drug Information Association/FDA 5th Workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making'. A major topic area at the 5th FDA/Industry Workshop on Pharmacogenomics, February 2-4, 2010 in Bethesda (MD, USA), was enabling pharmacogenomic clinical trials through collection of future use samples. The importance of the collection of samples with permission for future analyses was affirmed by both industry and the FDA. In addition, current barriers for the collection of such samples were detailed and possible solutions for overcoming barriers at sites, as well as globally within countries, were discussed. The importance of international concordance on collection of these samples was emphasized, and potential areas for industry to harmonize sample collection practices. A standalone workshop on issues related to sampling was determined to be a key step for solving issues related to future use sample collection during drug development.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
1744-8042
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
11
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1649-54
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Enabling pharmacogenomic clinical trials through sampling.
pubmed:affiliation
Merck Research Laboratories, North Wales, PA 19454, USA. amelia.warner@merck.com
pubmed:publicationType
Congresses