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Antibacterial drug development program successes and failures: a pharmacometric explanation
1Institute for Clinical Pharmacodynamics, United States.
Current Opinion in Pharmacology
|July 9, 2017
Summary
Drug development needs better dose selection for serious infections. Analyzing past program failures using pharmacometrics can prevent future predictable failures and improve rational dose selection.
Area of Science:
- Pharmacometrics
- Drug Development
- Infectious Diseases
Background:
- Current drug development practices often result in suboptimal dose regimens for serious infections.
- Past program failures in selecting effective doses highlight critical gaps in the process.
Purpose of the Study:
- To analyze historical drug development program failures and successes in dose selection for serious infections.
- To advocate for a pharmacometric approach to improve future dose regimen selection.
Main Methods:
- Review of past drug development programs, focusing on dose selection strategies.
- Application of pharmacometric principles to evaluate the predictability and avoidability of program failures.
- Analysis of data and thinking required for rational dose selection.
Main Results:
- Many program failures in dose selection were predictable and avoidable.
- Pharmacometric analysis provides a powerful lens to understand these failures.
- A systematic approach to dose selection is crucial for success.
Conclusions:
- Revisiting program failures through a pharmacometric lens is essential for advancing drug development.
- Improved thinking and data utilization are necessary for rational dose selection in serious infections.
- Implementing pharmacometric insights can lead to more successful drug development outcomes.
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