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This paper addresses the problem of power and sample size calculation for a stepwise multiple test procedure (SD2PC) proposed in Tamhane et al. [2001. Multiple test procedures for identifying the maximum safe dose. J. Amer. Statist. Assoc. 96, 835 843] to identify the maximum safe dose of a compound.
He was hit with a 1000-rem dofe of neutrons, more than twice the maximum safe dose, and was taken to the intensive care unit of the city hospital.
The maximum safe dose of Pa in the human body is 0.03 µCi, which corresponds to 0.5 micrograms of 231Pa.
The maximum safe dose of protactinium in the human body is 0.03 µCi that corresponds to 0.5 micrograms of 231Pa.
We therefore calculated that a concentration of 2 mg/ml would be the maximum safe dose that normal urothelial cells could withstand.
The modest predicted tumour pHe change in humans at the maximum safe dose emphasises the importance of using bicarbonate in conjunction with other therapies.
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In order to avoid serious complications (bone marrow suppression, lung fibrosis), the commonly used "maximum safe" administered dose concept published by Benua et al. [ 19] restricts the blood absorbed dose to less than 2 Gy (200 rad) and the whole-body retention to 4.4 GBq (120 mCi) at 48 h in the absence of diffuse lung metastases.
However, there is considerable controversy about the maximum safe iodine dose and duration of use when iodine is ingested in excess of the recommended daily dietary amount.
The maximum safe accumulated dose calculated using such an individualized method may be higher in a considerable number of patients and thereby this approach may also increase the maximum cumulative radiation dose to the tumour.
Equivalent doses for patients have been calculated using the FDA-recommended scaling factors for a first use in patients (Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078932.pdf).
A phase II clinical trial, which started in May 2013, is aiming to assess the feasibility, safety, toxicity, and maximum tolerated (safe) dose of the NSC treatment (ClinicalTrials.gov Identifier: NCT01730716).
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