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MeSH(Medical Subject Headings) ¸ÂÃã °Ë»ö (http://www.nlm.nih.gov) °á°ú : 5 ÆäÀÌÁö: 4
  • Clinical Trials - »õâ Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
    Synonyms : Trials, Clinical
  • Clinical Trials Data Monitoring Committees - »õâ Committees established to review interim data and efficacy outcomes in CLINICAL TRIALS. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
    Synonyms : Data Monitoring Committees, Board, Safety Monitoring, Boards, Safety Monitoring, Committee, Data Monitoring, Committees, Data Monitoring, Data Monitoring Committee, Monitoring Board, Safety, Monitoring Boards, Safety, Monitoring Committee, Data
  • Clinical Trials, Phase I - »õâ 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.
    Synonyms : Clinical Trials, Phase 1, Drug Evaluation, FDA Phase 1, Evaluation Studies, FDA Phase 1, Human Microdosing Trials, Microdosing Trials, Human, Phase 1 Clinical Trials, Human Microdosing Trial, Microdosing Trial, Human, Trial, Human Microdosing
  • Clinical Trials, Phase II - »õâ Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
    Synonyms : Clinical Trials, Phase 2, Drug Evaluation, FDA Phase 2, Evaluation Studies, FDA Phase 2, Phase 2 Clinical Trials
  • Clinical Trials, Phase III - »õâ Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.
    Synonyms : Clinical Trials, Phase 3, Drug Evaluation, FDA Phase 3, Evaluation Studies, FDA Phase 3, Phase 3 Clinical Trials
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MeSH(Medical Subject Headings) À¯»ç °Ë»ö (http://www.nlm.nih.gov) °á°ú : 0 ÆäÀÌÁö: 4
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