Matches in DBpedia 2016-04 for { <http://wikidata.dbpedia.org/resource/Q17005771> ?p ?o }
Showing triples 1 to 18 of
18
with 100 triples per page.
- Q17005771 subject Q20929517.
- Q17005771 subject Q7056690.
- Q17005771 subject Q8463108.
- Q17005771 abstract "The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.".
- Q17005771 wikiPageExternalLink DrugLag.html.
- Q17005771 wikiPageWikiLink Q1367466.
- Q17005771 wikiPageWikiLink Q204711.
- Q17005771 wikiPageWikiLink Q20929517.
- Q17005771 wikiPageWikiLink Q2368661.
- Q17005771 wikiPageWikiLink Q5238822.
- Q17005771 wikiPageWikiLink Q5425270.
- Q17005771 wikiPageWikiLink Q6542690.
- Q17005771 wikiPageWikiLink Q7056690.
- Q17005771 wikiPageWikiLink Q7180990.
- Q17005771 wikiPageWikiLink Q7727289.
- Q17005771 wikiPageWikiLink Q8463108.
- Q17005771 comment "The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients.".
- Q17005771 label "FDA Accelerated Approval".