Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The economics of developing antibacterials is a frustrating topic to address. There are unique aspects to the antibiotic market which sets it apart from other medicines, esp. the unique societal aspects of antibiotic use which go beyond the benefit to the individual. IDSA has spoken out in various publications (“Bad Continue reading It’s Not a Free-Enterprise Market, Stupid!
Several antibiotic classes are associated with QTc prolongation: macrolides, quinolones, the antimalarials that share the quinine structure, and many azole antifungals. FDA warned about the proarrhythmic effects of azithromycin in 2013 [i] but it is a recent publication by Rao which brings the message home again with some very disquieting Continue reading QT Prolongation with Azithromycin and Levofloxacin
As antibiotic resistance increases over the years, originally established susceptibility breakpoints (S-I-R) are becoming less relevant. This ‘creep’ towards higher MICs over time is a unique but well-known feature of antimicrobials ultimately making these drugs obsolete. In the past, FDA and CLSI did not bother to update breakpoints in Continue reading The Breakpoint Dilemma