Achieving sufficient bioavailability with oral picoplatin is extremely encouraging and supports the further clinical development of an oral formulation of the drug, because it is a convenient, flexible dosing routine for patients who would provide benefit to picoplatin, said Robert De Jager, chief medical officer of Poniard. Four weeks later,istered picoplatin may be desirable for cancer patients receiving radiation therapy, and in combination with other oral therapies. .
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Phase 1 Study Design and ResultsPoniard the randomized, open-label, dose – escalation Phase 1 study was conducted at clinical sites in the U.S. The study compared the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin orally with picoplatin administered intravenously in patients with advanced solid tumors tumors. Bioavailability refers to the proportion of an administered dose of unchanged drug In the first part systemic circulation. In the first part of this two-part study, patients were randomized with advanced solid tumors, malignant tumors of a single dose of either intravenous or oral picoplatin . Four weeks later, to a second to a second single picoplatin administered dose via the alternative pathway.In the interests to the health care the American people, and the timely reauthorization of PDUFA and MDUFMA, I strongly encourage of U.S. Senate, FDA accounting, does not not happen to drugs imported language of like which Dorgan change in.
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