|
1 / 1
|
DeCS
|
|
 |
|
Descriptor English:
|
|
Clinical Trials, Phase I as Topic
|
|
Descriptor Spanish:
|
|
Ensayos Clínicos Fase I como Asunto
|
|
Descriptor Portuguese:
|
|
Ensaios Clínicos Fase I como Assunto
|
|
Synonyms English:
|
|
Clinical Trials, Phase I
Drug Evaluation, FDA Phase I
Evaluation Studies, FDA Phase I
Phase I Clinical Trials
|
|
Tree Number:
|
|
E05.318.760.535.200
E05.337.250.200
N05.715.360.775.235.200
N06.850.520.450.535.200
VS2.002.003.001.003.001
|
|
Definition English:
|
|
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. |
|
Indexing Annotation English:
|
|
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
|
|
See Related English:
|
|
Nontherapeutic Human Experimentation
|
|
History Note English:
|
|
2008(1993)
|
|
Allowable Qualifiers English:
|
|
|
|
Record Number:
|
|
30784
|
|
Unique Identifier:
|
|
D017321
|
Occurrence in VHL:
|
|
|
Similar:
|
|
DeCS CID-10 SciELO LILACS LIS
|