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In this chapter, we describe the steps necessary to develop this novel approach from the selection of a physiologically and biologically promising biodegradable polymer system; to the preclinical studies demonstrating the safety and efficacy of polymer drug delivery to the brain; to the clin- ical trials that finally lead to the FDA approval of BCNU (carmustine) loaded polymer (GliadelВ) for the treatment of malignant glial tumors. 1287 Procaine hydrochloride . TIMING OF LIVER TRANSPLANTATION A sound knowledge of the natural history of disease is essential in the decision making process vis-aМ-vis the timing of transplantation. C-6.
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