Noxafil Exposure-Response Findings, Composite Endpoint Perplexed FDA
This article was originally published in Pharmaceutical Approvals Monthly
Data suggesting an association between clinical failure and low plasma exposure to Schering-Plough's antifungal Noxafil (posaconazole) emerged as a major review issue in the context of the variability of posaconazole exposure in trials, FDA review documents show
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