About: Animal efficacy rule

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The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism.

Attributes	Values
rdfs:label	Animal Efficacy Rule (de) Animal efficacy rule (en)
rdfs:comment	The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism. (en) Die Animal Efficacy Rule (engl.: efficacy = Wirksamkeit) ist ein von der US-amerikanischen Food and Drug Administration (FDA) im Jahr 2002 etabliertes Zulassungsverfahren für bestimmte Arzneimittel. Diese Arzneimittel müssen vor ernsthaften oder lebensbedrohlichen, durch die Exposition mit Noxen hervorgerufenen, Erkrankungen schützen oder diese zumindest lindern, wobei klinische Studien zur Überprüfung der Wirksamkeit am Menschen aus ethischen oder praktischen Gründen nicht durchführbar sind. In diesen Fällen genügt der Wirksamkeitsnachweis an Modellorganismen im Tierversuch. (de)
dcterms:subject	Biological contamination Biopharmaceuticals Biotechnology Biological warfare Pharmacy Animal testing Bioethics Life sciences industry Pharmaceutical industry Biotechnology products Specialty drugs
Wikipage page ID	24461363 (xsd:integer)
Wikipage revision ID	1081481228 (xsd:integer)
Link from a Wikipage to another Wikipage	Animal testing Biological contamination Biopharmaceuticals United States Congress Biotechnology Clinical endpoint Clinical research ethics Clinical trial Pharmacodynamics Biological warfare Pharmacy Drug Drug development Food and Drug Administration (United States) Animal testing Bioethics Life sciences industry Pharmaceutical industry Biotechnology products Specialty drugs Biological agent Biopharmaceutical Bioterrorism Effective dose (pharmacology) Toxicity September 11 attacks Pharmacokinetics Radiological weapon Chemical agent
Link from a Wikipage to an external page	https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm070766.htm%23q14 https://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm
sameAs	Animal efficacy rule Animal efficacy rule Animal efficacy rule Animal efficacy rule
dbp:wikiPageUsesTemplate	dbt:Reflist dbt:Biotechnology dbt:Toxicology dbt:Bioterrorism dbt:U.S._biological_defense
has abstract	The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism. (en) Die Animal Efficacy Rule (engl.: efficacy = Wirksamkeit) ist ein von der US-amerikanischen Food and Drug Administration (FDA) im Jahr 2002 etabliertes Zulassungsverfahren für bestimmte Arzneimittel. Diese Arzneimittel müssen vor ernsthaften oder lebensbedrohlichen, durch die Exposition mit Noxen hervorgerufenen, Erkrankungen schützen oder diese zumindest lindern, wobei klinische Studien zur Überprüfung der Wirksamkeit am Menschen aus ethischen oder praktischen Gründen nicht durchführbar sind. In diesen Fällen genügt der Wirksamkeitsnachweis an Modellorganismen im Tierversuch. (de)
prov:wasDerivedFrom	wikipedia-en:Animal_efficacy_rule?oldid=1081481228&ns=0
page length (characters) of wiki page	4049 (xsd:nonNegativeInteger)
foaf:isPrimaryTopicOf	wikipedia-en:Animal_efficacy_rule
is Link from a Wikipage to another Wikipage of	Animal Efficacy Rule The Demon in the Freezer Entolimod Anthrax immune globulin Statera BioPharma Emergency Use Authorization Ebola virus disease treatment research Ebola vaccine
is Wikipage redirect of	Animal Efficacy Rule
is foaf:primaryTopic of	wikipedia-en:Animal_efficacy_rule

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