Allphase Pharma Consulting, LLC
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US doctors seem to be very willing to start drugs earlier in disease, while their EU colleagues are slower and more conservative. Recent examples: the ever-wider indication for statins, the disproportionate uptake of drugs for attention-deficit / hyperactivity and opioids Continue reading HIV Therapy Guidance Recommendations Diverge, Show US Bias
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, Continue reading The Breakpoint Dilemma
FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair: Looking at the reviewer’s slides, there was really no question about the drug’s efficacy. Did tedizolid cure as many patients as linezolid? Yes, it did. Did the sponsor follow Continue reading FDA Adboard on Tedizolid – Why?