Tag Archives: AOM

Efficacy and Treatment Duration: Where is the Tipping Point?

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Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; for antibiotics, however, an effective dose can be predicted nowadays Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?→

Is the AOM Indication Making a Come-Back?

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We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue shortly after the 1998 FDA Guidelines were published. The arguments Continue reading Is the AOM Indication Making a Come-Back?→

The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm

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The cartilage damage caused by fluoroquinolones in juvenile beagle dogs is not subtle:  blister formation and erosions occur in a dose-dependent fashion resulting in reversible cartilage damage.  These lesions can be seen not just histologically but even macroscopically.  The animals are unable to walk as weight-bearing joints are predominantly affected.  Continue reading The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm→