Concept information
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Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
...
Epidemiologic Methods
Epidemiologic Study Characteristics
Clinical Studies as Topic
Clinical Trials as Topic
Preferred term
Clinical Trials, Phase I as Topic
Type
-
Topical Descriptor
Broader concept
Entry terms
- Clinical Trials, Phase 1
- Clinical Trials, Phase I
- Phase 1 Clinical Trial
- Phase 1 Clinical Trials
- Phase I Clinical Trial
- Phase I Clinical Trials
Note
- for general design, methodology, economics, etc. of phase I clinical trials; a different heading CLINICAL TRIAL, PHASE I is used for reports of a specific phase I clinical trial
Scope note
- Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
History note
- 2008(1993)
In other languages
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Finnish
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Swedish
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Evalueringsstudier, FDA fas 1
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Fas 1 kliniska prövningar
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Lälkemedelsprövning, FDA fas I som ämne
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Utvärderingsstudier, FDA fas I
URI
http://www.yso.fi/onto/mesh/D017321
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