Allphase Pharma Consulting, LLC
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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
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 together, CAP was not differentiated from HAP, and HAP and Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?
The cartilage damage caused by fluoroquinolones in juvenile beagle dogs is not subtle: blister formation and erosions occur in a dose-dependent fashion resulting in reversible cartilage damage. These lesions can be seen not just histologically but even macroscopically. The animals are unable to walk as weight-bearing joints are predominantly affected. Continue reading The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm