Matches in DBpedia 2016-04 for { <http://dbpedia.org/resource/Expanded_access> ?p ?o }
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- Expanded_access abstract "Expanded access (also known as compassionate use) refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Outside the US, such access is allowed through Named patient programs. In the US this type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP). EAPs can be leveraged in a wide range of therapeutic areas including HIV/AIDS and other infectious diseases, cancer, rare diseases, and cardiovascular diseases, to name a few.There are several types of EAPs allowed in the United States. Treatment protocols and treatment INDs provide large numbers of patients access to investigational drugs. A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to an investigational drug on an emergency or compassionate use basis. When the FDA receives a significant number of requests (~10 to 100) for individual patient expanded access to an investigational drug for the same use, they may ask the trial sponsor to consolidate these requests, creating an intermediate-size group. “Compassionate use” is a more colloquial term that is not generally used by the FDA.".
- Expanded_access wikiPageExternalLink 522052.
- Expanded_access wikiPageExternalLink articleDetail.jsp?id=453246.
- Expanded_access wikiPageExternalLink 26?s=0.
- Expanded_access wikiPageExternalLink 04_SB8K8xLLM9MSSzPy8xBz9CP0os3iLkCAPEzcPIwP_AH9TAyNTIxcjX2NTQ2dHM_1I_ShznPK-pvohIBMz9SNNLSwtQcxi_UgDEF2gH2lsoV-QnZhUlRqpCACSGBYo.
- Expanded_access wikiPageExternalLink SB124121952867078963.html.
- Expanded_access wikiPageExternalLink 517397.
- Expanded_access wikiPageExternalLink EAPGuidelines2005Mar12.pdf.
- Expanded_access wikiPageExternalLink ucm172492.htm.
- Expanded_access wikiPageExternalLink 17untested.html?_r=2&ref=policy.
- Expanded_access wikiPageID "10843800".
- Expanded_access wikiPageLength "13497".
- Expanded_access wikiPageOutDegree "10".
- Expanded_access wikiPageRevisionID "703778456".
- Expanded_access wikiPageWikiLink Category:Clinical_pharmacology.
- Expanded_access wikiPageWikiLink Category:Medical_research.
- Expanded_access wikiPageWikiLink Clinical_trial.
- Expanded_access wikiPageWikiLink Food_and_Drug_Administration.
- Expanded_access wikiPageWikiLink AIDS.
- Expanded_access wikiPageWikiLink Investigational_New_Drug.
- Expanded_access wikiPageWikiLink Named_patient_programs.
- Expanded_access wikiPageWikiLink Odds_algorithm.
- Expanded_access wikiPageWikiLink Phases_of_clinical_research.
- Expanded_access wikiPageWikiLinkText ""compassionate use"".
- Expanded_access wikiPageWikiLinkText "Expanded access".
- Expanded_access wikiPageWikiLinkText "compassionate use".
- Expanded_access wikiPageWikiLinkText "drug case".
- Expanded_access wikiPageWikiLinkText "expanded access".
- Expanded_access wikiPageUsesTemplate Template:Reflist.
- Expanded_access wikiPageUsesTemplate Template:Wiktionary.
- Expanded_access subject Category:Clinical_pharmacology.
- Expanded_access subject Category:Medical_research.
- Expanded_access type Science.
- Expanded_access comment "Expanded access (also known as compassionate use) refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Outside the US, such access is allowed through Named patient programs.".
- Expanded_access label "Expanded access".
- Expanded_access sameAs Q407954.
- Expanded_access sameAs Compassionate_Use.
- Expanded_access sameAs Cura_compassionevole.
- Expanded_access sameAs 동정적사용승인계획.
- Expanded_access sameAs m.02qrr85.
- Expanded_access sameAs Uz_compasional.
- Expanded_access sameAs Sočutna_uporaba_zdravil.
- Expanded_access sameAs Q407954.
- Expanded_access wasDerivedFrom Expanded_access?oldid=703778456.
- Expanded_access isPrimaryTopicOf Expanded_access.