Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’. As a QIDP drug, Avycaz received priority review. Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It
Sometimes an article pops up addressing a question we have been mulling over for quite some time. It so happened with a recent publication which shed new light on penem dosing for ICU patients[1]. Conducted at a single Belgian centre (sic!), a standard dose of meropenem (1 g IV q8h Continue reading Meropenem Dosing for VAP: High + Prolonged Beats Conventional Dosing