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This is a somewhat nostalgic retro blog. I was leafing through a book by Vince Andriole called ‘The Quinolones’.[1] First released in 1988, its third edition is from 2000. It provided in-depth coverage of quinolone chemistry, PK, microbiology, efficacy and safety. It was a great review of the large and Continue reading ANTIBIOTIC DEVELOPMENT IN PHARMA IS DEAD – FOR NOW
Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; for antibiotics, however, an effective dose can be predicted nowadays Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
Any FDA meeting is a high-stakes game for industry: One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective. At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?