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Topotecan could not be safely administered in the approved single agent (1.5 mg m−2) daily times five schedule.
This dose is very close to the officially approved single agent dose of irinotecan of 350 mg m−2, which has also been the maximally tolerated dose proposed from phase I studies.
Of the 462 patients receiving chemotherapy, 286 patients were eligible and enrolled in various clinical trials, whereas in the remaining 176 patients, different approved single or combination anti-cancer agents were used.
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The Caya® Diaphragm is a newly approved single-size, nonlatex diaphragm.
The currently approved single-use formulation of rFVIIa is freeze dried and is stable for up to 3 years when stored at 2°C to 8°C (36°F-46°F 36°F-46°F
The trials included in this review evaluated the potential impact on HPA axis function of eight approved single-ingredient ICS and INS (beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone furoate, flucticasone propionate, mometasone furoate, and triamcinolone acetonide) and combination products containing these ingredients.
12– 14 Fixed-dose combination rilpivirine-tenofovir-emtricitabine represents a more recently approved single-tablet regimen.
Therefore, confirming the lack of interaction (i.e. the proteins act independently) in insect bioassays provides a mechanism to link the existing body of evidence on non-target toxicity of the individual proteins in the previously approved single-event products.
Topotecan is currently the only approved single-agent for second-line therapy and recent data with oral topotecan show that more of these patients than suggested earlier can achieve further responses, symptom control and survival prolongation.
Two hundred and nine Caucasian children and adolescents 4 months to 17 years old at the time of cancer diagnosis were eligible for this prospective Institutional Review Board approved single-center study performed at the Department of Pediatrics, Masaryk University in Brno, Czech Republic.
"We will not approve single-benefit waivers," the health agency spokesman, Rob Sweezy, said this week.
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