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Tag Archives: efficacy margins

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

Posted on October 27, 2016 by Harald — No Comments ↓

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→

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Posted in QIDP Antibiotics, Recent Literature, The News, The Viewpoint | Tagged AIDAC, Allphase Pharma Consulting, AMDAC, antibiotic blog, Avelox, CABP Guidance, Cempra, delta, drotrecogin, efficacy criteria, efficacy margins, FDA, FDA vs EU guidelines, File, Harald Reinhart, IV site reactions, IV/PO, ketolide, loading dose, macrolide, moxifloxacin, NI, non-inferiority, PORT score, SOLITAIRE-IV, SOLITAIRE-ORAL, tigecycline, Tygacil, Xigris | Leave a reply
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