Matches in DBpedia 2016-04 for { <http://wikidata.dbpedia.org/resource/Q5179236> ?p ?o }
Showing triples 1 to 13 of
13
with 100 triples per page.
- Q5179236 subject Q6933255.
- Q5179236 subject Q8463108.
- Q5179236 abstract "In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (FDA) as part of a marketing application (for example, as part of an NDA or 510(k)), about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as "...any study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or any study in which a single investigator makes a significant contribution to the demonstration of safety."".
- Q5179236 wikiPageWikiLink Q1368197.
- Q5179236 wikiPageWikiLink Q204711.
- Q5179236 wikiPageWikiLink Q2198549.
- Q5179236 wikiPageWikiLink Q30612.
- Q5179236 wikiPageWikiLink Q3067874.
- Q5179236 wikiPageWikiLink Q5133835.
- Q5179236 wikiPageWikiLink Q6933255.
- Q5179236 wikiPageWikiLink Q8463108.
- Q5179236 comment "In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (FDA) as part of a marketing application (for example, as part of an NDA or 510(k)), about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation.".
- Q5179236 label "Covered clinical study".