Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA
‘He who knows syphilis knows medicine’ goes the saying. In a similar way this adage could be applied to the Pneumococcus, aka Streptococcus pneumoniae, Diplococcus pneumoniae or Diplococcus lanceolatus by saying “He who knows S. pneumoniae knows microbiology”. Many ‘big names’ studied the organism. Their work on the Pneumococcus led to Continue reading The Pneumococcus, Prominent Microbiologists, Contributions and Cross-Connections
I find it useful to look back and review drug candidates that were stopped in development. In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug. More importantly, we want to learn about the Continue reading Discontinued But Not Forgotten: HCV Drugs That Did Not Make It