Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The website “ClinicalTrials.gov” has become the first stop for many of us who need to check on trial activity of a particular drug. All larger human Phase 2 – 4 trials are listed there in quite some detail. While companies sometimes shy away from publishing full entry criteria or primary Continue reading And the Results are …Pending
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 for pain relief. The new US HIV treatment guidelines are 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, FDA and CLSI did not bother to update breakpoints in Continue reading The Breakpoint Dilemma