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Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding

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A recent paper by Thabit describes a curious finding [1]. The authors measured total and free (i.e., nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up total doses. The effect was rather dramatic: an increase in protein binding from 12% Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding→

Choose your Outcome: How Design Minutiae Affect Trial Results

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When you search for ‘ceftidoren’ on Wikipedia, you will get a surprise: there is no entry. However, a search on the web tells us that Spectracef (ceftidoren pivoxil) still exists. Gee, now the drug is spelled ‘cefditoren’ and – looking through the list of retrieved articles – it seems that Continue reading Choose your Outcome: How Design Minutiae Affect Trial Results→

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

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Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?→