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Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

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Often we come across a study which raises more questions than it answers.  Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Occasionally we encounter studies with results that are so counterintuitive Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui→

Profiling Solithromycin: FDA AMDAC on Solithera

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Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for the next new B-lactam or quinolone regardless of whether during Continue reading Profiling Solithromycin: FDA AMDAC on Solithera→

Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

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Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty penmanship it is, if you haven’t noticed. Just as a Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug→