منابع مشابه
Pulmonary carcinogenicity of inhaled particles and the maximum tolerated dose.
Chronic inhalation bioassays in rodents are used to assess pulmonary carcinogenicity for purposes of hazard identification and potentially for risk characterization. The influence of high experimental doses on tumor development has been recognized for some time and has led to the concept of maximum tolerated dose (MTD) for dose selection, with the highest dose being at the MTD. Exposure at the ...
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Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent 'confirmatory' Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationsh...
متن کاملLiposomal cisplatin dose escalation for determining the maximum tolerated dose and dose-limiting toxicity: a phase I study.
BACKGROUND The aim of the present trial was to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of liposomal cisplatin (lipoplatin) using nephrotoxicity, gastrointestinal toxicity and myelotoxicity as the main adverse reactions. PATIENTS AND METHODS Lipoplatin, a liposomal formulation of cisplatin was first tested as monotherapy starting at a dose of 125 mg/m(2) and...
متن کاملReevaluation of the maximum tolerated dose of continuous venous infusion of 5-fluorouracil with pharmacokinetics.
5-Fluorouracil (5-FU) was administered as a continuous ambulatory venous infusion to 25 patients in a Phase I trial. The principal dose limiting toxic effect observed was mucositis. Skin rash and diarrhea occurred less frequently. Hematological toxicity was modest, and no hepatic toxicity was seen. One partial remission of 138 days duration was seen in a patient with metastatic breast carcinoma...
متن کاملMaximum Tolerated Dose of Nalmefme in Patients Receiving Epidural Fentanyl and Dilute Bupivacaine
Background: This study investigated the ability of the modified continual reassessment method (MCRM) to determine the maximum tolerated dose of the opioid antagonist nalmefene, which does not reverse analgesia in an acceptable number of postoperative patients receiving epidural fentanyl in 0.075% bupivacaine. Methods: In the postanesthetic care unit, patients received a single intravenous dose ...
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ژورنال
عنوان ژورنال: British Journal of Clinical Pharmacology
سال: 2019
ISSN: 0306-5251,1365-2125
DOI: 10.1111/bcp.14032