Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators. There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS – 1
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
SIRS, sepsis, severe sepsis, septic shock is a continuum, a crescendo of signs and symptoms associated with an infection uncontrolled by host responses. An avalanche or cascade of seemingly unstoppable events occurs often in a matter of hours which has defied causal intervention but for which symptomatic treatment has improved Continue reading Recent Sepsis Literature