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Clinical Trials, Phase I as Topic
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Definition of 'Clinical Trials, Phase I as Topic'

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.

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Monday, November 23, 2009

Characteristics of children enrolled in treatment trials for NF1-related plexiform neurofibromas.

18 Oct 2009 OBJECTIVE: To describe the characteristics of children enrolled in treatment trials for neurofibromatosis type 1 (NF1)-related plexiform neurofibroma (PN), PN tumor burden, PN-related complications, and treatment outcomes and to highlight the ... Read more...


Attacking cancer at its root.

16 Sep 2009 This year the Lasker DeBakey Clinical Research Award will be shared by Brian Druker, Nicholas Lydon, and Charles Sawyers for their development of a targeted molecular therapy for treating chronic myeloid leukemia. Their work demonstrated the ability ... Read more...


Human pharmacokinetics/pharmacodynamics of an interleukin-4 and interleukin-13 dual antagonist in asthma.

30 Aug 2009 Pitrakinra, a 15-kDa recombinant human interleukin-4 mutein, targets allergic Th2 inflammation by competitively binding to interleukin-4 receptor alpha to interfere with interleukin-4 and interleukin-13 action. The authors characterized pitrakinra ... Read more...

 

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Technical information about 'Clinical Trials, Phase I as Topic'

Definition: 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.

Descriptor UI: D017321

Alternative terms: Clinical Trials, Phase I as Topic; Clinical Trials, Phase I; Phase 1 Clinical Trials; Phase I Clinical Trials; Clinical Trials, Phase 1; Evaluation Studies, FDA Phase I; Evaluation Studies, FDA Phase 1; Microdosing Trials, Human; Human Microdosing Trial; Microdosing Trial, Human; Trial, Human Microdosing; Trials, Human Microdosing; Human Microdosing Trials; Drug Evaluation, FDA Phase I as Topic; Drug Evaluation, FDA Phase I; Drug Evaluation, FDA Phase 1;

Related Mesh Headings: Nontherapeutic Human Experimentation;

Allowable Qualifiers: adverse effects; classification; economics; history; instrumentation; methods; mortality; nursing; psychology; standards; trends; utilization; veterinary; statistics & numerical data; contraindications; ethics; legislation & jurisprudence;

Tree Number: E05.318.760.535.200; E05.337.250.200; N05.715.360.775.235.200; N06.850.520.450.535.200;

History Note: 2008(1993)

Technical Notes: 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

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