Legally cautious points on phase I clinical study.
نویسندگان
چکیده
منابع مشابه
Phase I clinical trials
Phase I trials are conducted to find a dose to use in subsequent trials. They provide data on the rate of adverse events at different dose levels and provide data for studying the pharmacokinetics and pharmacology of the drug. Dose-finding studies that involve therapies with little or no toxicity often enroll healthy volunteers and usually have a control group. Trials in oncology and other life...
متن کاملPhase I clinical and pharmacological study of chloroquinoxaline sulfonamide.
Chloroquinoxaline sulfonamide (CQS) is a halogenated heterocyclic sulfanilamide identified by the in vitro human tumor colony-forming assay as an active agent in a variety of human solid tumors. In this phase I study, 182 courses of CQS were administered intravenously every 28 days to 88 patients at doses ranging from 18 to 4870 mg/m2. Hypoglycemia associated with hyperinsulinemia was the dose-...
متن کاملPhase I clinical and pharmacological study of merbarone.
Merbarone, a nonsedating derivative of thiobarbituric acid, has demonstrated excellent activity against certain murine tumors, including L1210 and P388 leukemias, B16 melanoma, and M5076 sarcoma. Preclinical studies suggested that the antitumor effects of this drug were schedule dependent, since repeated dosing increased killing of tumor cells when compared to intermittent injections. We have c...
متن کاملPhase I Clinical and Pharmacological Study of Merbarone1
Merbarone, a nonsedating derivative of thiobarbituric acid, has dem onstrated excellent activity against certain murine tumors, including LI210 and P388 leukemias, B16 melanoma, and M5076 sarcoma, froclinical studies suggested that the antitumor effects of this drug were schedule dependent, since repeated dosing increased killing of tumor cells when compared to intermittent injections. We have ...
متن کاملPhase I Clinical Study of Edaravone in Healthy Chinese Volunteers
OBJECTIVE The objective of this study was to investigate the safety and pharmacokinetics of edaravone administered by single or successive intravenous infusions in healthy Chinese volunteers. METHODS A total of 30 subjects (15 males and 15 females) were recruited and randomly assigned to three groups receiving edaravone doses of 20, 30, and 60 mg. All subjects received a single dose of edarav...
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ژورنال
عنوان ژورنال: Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
سال: 1994
ISSN: 1882-8272,0388-1601
DOI: 10.3999/jscpt.25.343