Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably
In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums. Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice
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. Continue reading Why Some Did Not Make It
When imipenem is dosed at 1 g q8h for serious infections, it is infused over 40-60 min. Its label states that it is indicated for “lower RTI”, an old-fashioned term from the days when bronchitis and pneumonias were still lumped Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?