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A framework to guide dose & regimen strategy for clinical drug development.
Oliver Sander1, Baldur Magnusson1, Inga Ludwig1
1Novartis Pharma AG, Basel, Switzerland.
CPT: Pharmacometrics & Systems Pharmacology
|September 25, 2021
Summary
Optimizing drug therapies is complex. This study introduces a new framework to aid clinical development teams in organizing knowledge and fostering collaboration for better treatment decisions.
Area of Science:
- Clinical pharmacology
- Drug development science
- Quantitative methodologies in medicine
Background:
- Optimizing new drug therapies presents significant challenges in clinical development.
- Sophisticated quantitative methodologies are increasingly used but do not fully resolve these challenges.
- Balancing therapeutic risks and benefits for individual patients requires a multidisciplinary approach.
Purpose of the Study:
- To present a novel framework designed to enhance knowledge organization.
- To facilitate improved collaboration among multidisciplinary drug development teams.
- To address the complexities of personalized medicine and dose optimization.
Main Methods:
- Development of a conceptual framework for drug development.
- Focus on knowledge organization and team collaboration strategies.
- Integration of multidisciplinary insights into a cohesive tool.
Main Results:
- The proposed framework provides a structured approach to complex drug development problems.
- It enhances the ability of development teams to organize information effectively.
- It serves as a tool to facilitate better communication and collaboration.
Conclusions:
- The presented framework offers a valuable approach to optimizing new drug therapies.
- It supports multidisciplinary teams in achieving a better risk-benefit balance.
- This tool can improve the efficiency and effectiveness of clinical development processes.
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