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In pre-clinical studies, SAVVY demonstrated minimal toxicity at 0.001% concentration, as measured by the cell proliferation assay, and no toxicity to mammalian cells at 0.0003%, as measured by the MTT assay [5].

SP-G has recently completed a phase I clinical trial where it shows minimal toxicity at therapeutic plasma concentrations (Clive et al, 2001).

Preliminary studies analyzed a range of malathion concentrations (25 100 μg/mL) and time points (0 24 hr) and showed minimal toxicity at 24 hr with a final concentration of 50 μg/mL.

Preliminary studies analyzed a range of OTQ concentrations (0 – 12.5 μM) selected based on previous research [ 6, 7] and time points (0 – 24 hours), and showed maximum effect of OTQ on p53 expression with minimal toxicity at 2 hours with a final concentration of 6.25 μM.

Blinded dose adjustments of 1.5 mg/kg/day were permitted according to efficacy and safety outcome, with the dosage being incremented in cases of insufficient response accompanied by minimal toxicity at weeks 4 and 8 to a maximum dose of 7.5 mg/kg/day (that is, one additional 100 mg tablet is required for a 66 kg patient previously receiving 6 mg/kg/day to achieve the theoretical dose of 495 mg).

Similar(55)

This is consistent with the clinical finding, during the dose-escalation study, that despite its higher FU-dose intensity, MdG at this dose has the same minimal toxicity as standard dG.

CFRPBT showed no toxicity in bulk form and only minimal toxicity as a particulate.

Thus, because we have adopted a Phase II approach with small numbers of patients, we cannot exclude a role for this combination in the treatment of a subgroup of patients that might tolerate treatment with minimal toxicity even at higher doses, and which may also have a higher response rate.

In a Phase I/II, clinical activity with minimal toxicity was observed at multiple dose levels in mutant BRAF tumors [9].

Minimal toxicity was observed at doses up to and including 8 mg/m.

Many CPPs display minimal toxicity and immunogenicity at physiologically relevant concentrations, and the incorporation of specific unnatural amino acids and other chemical moieties has been found to increase the stability and extent of cytosolic delivery.

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