Allphase Pharma Consulting, LLC
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It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to change a clinically relevant measure (the “feel, function, survive” mantra Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem
There is much interest in inhaled antibiotics these days. Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy plus optimized safety combined. However, some high-profile failures were published Continue reading Antibiotic Inhalers Galore (Part 1): More Combinations and Permutations than a Rubik’s Cube
According to Janet Woodcock, 63 drugs have been given the “QIDP” designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development. So we are in fairly close agreement. That may seem like an impressive record but it is also Continue reading QIDP Drug Update – Part 2: Categories of Interest