Phase I clinical trials of anticancer drugs in healthy volunteers: Need for critical consideration
نویسندگان
چکیده
منابع مشابه
Phase 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...
متن کاملPhase 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 کاملPsychotropic drugs and paediatrics: a critical need for more clinical trials.
Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in paediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children. This paper briefly reviews the factors associated with the lack of paediatric clinical trials. We advocate a shif...
متن کاملA Bayesian Adaptive Design for Combination of Three Drugs in Cancer Phase I Clinical Trials
We describe a Bayesian adaptive design for early phase cancer trials of a combination of three agents. This is an extension of an earlier work by the authors by allowing all three agents to vary during the trial and by assigning different drug combinations to cohorts of three patients. The primary objective is to estimate the Maximum Tolerated Dose (MTD) surface in the three-dimensional Cartesi...
متن کاملPerforming phase I clinical trials of anticancer agents: perspectives from within the European union and Japan.
Drug discovery and early clinical development is an international endeavor, conducted in partnership between commercial entities such as biotechnology and pharmaceutical companies and academic investigators. Although once considered quite disparate, early clinical trials requirements and conduct are largely harmonized between the European Union, Japan, and the United States, increasing the oppo...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Indian Journal of Pharmacology
سال: 2012
ISSN: 0253-7613
DOI: 10.4103/0253-7613.99350