A trial design in which neither the researcher nor the patient knows the details of the treatment the patient was randomly assigned to.
EnumerationMember
FDAcategoryC
health-lifesci.schema.org
A designation by the US FDA signifying that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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EnumerationMember
FDAcategoryD
health-lifesci.schema.org
A designation by the US FDA signifying that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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EnumerationMember
FDAcategoryX
health-lifesci.schema.org
A designation by the US FDA signifying that studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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