Antibacterial drug development program successes and failures: a pharmacometric explanation

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HIGHLIGHTSAntibiotic development program success and failure viewed through pharmacometrics.Program failures are not only predictable, but expected and entirely avoidable.Pharmacometrics supports the conduct of smaller clinical trials.My thesis is a simple one. We have not been doing a good enough job selecting dose regimens for serious infections during the drug development process. If we are to do a better job in the future, we need to revisit some uncomfortable places. That is, some notable program failures. To be clear, we are not revisiting program failures to make anyone uncomfortable or cast aspersions — but rather so that we sow the seeds for a better future. To that end, we will examine program failures and successes through a pharmacometric lens. Through this powerful lens, we will come to understand that many of our failures were not only predictable, but perhaps expected and entirely avoidable. The goal of this communication is to set forth the type of thinking and data that is necessary for rational dose selection.

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