Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes
A recent paper by Thabit describes a curious finding [1]. The authors measured total and free (i.e., nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up total doses. The effect was rather dramatic: an increase in protein binding from 12% Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding