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Concepts and challenges in quantitative pharmacology and model-based drug development
Liping Zhang1, Marc Pfister, Bernd Meibohm
1Bristol Myers Squibb Research and Development, Princeton, New Jersey, USA.
The AAPS Journal
|November 13, 2008
Summary
Model-based drug development (MBDD) offers a paradigm shift to enhance drug discovery efficiency. Implementing MBDD requires changes in mindset, processes, and organizational collaboration for greater success.
Area of Science:
- Pharmacometrics and Drug Development
- Quantitative Pharmacology
- Systems Pharmacology
Background:
- Model-based drug development (MBDD) is recognized for improving drug development efficiency.
- Despite growing acceptance, current practices remain distant from full MBDD integration.
- Key concepts like PK-PD modeling and pharmacometrics require clear distinction within MBDD.
Purpose of the Study:
- To clarify the concept of Model-based drug development (MBDD).
- To propose practical implementation strategies for MBDD in the pharmaceutical industry.
- To differentiate MBDD from related quantitative pharmacology disciplines.
Main Methods:
- Conceptual clarification of MBDD and related terms (PK-PD, exposure-response, pharmacometrics, quantitative pharmacology).
- Analysis of current drug development practices versus MBDD principles.
- Framework proposal for MBDD implementation across organizational levels.
Main Results:
- MBDD is defined as a paradigm and mindset, not just a technique.
- MBDD encompasses the entire drug development spectrum.
- Successful MBDD implementation necessitates changes in organizational mindset, adaptive processes, and collaborative structures.
Conclusions:
- Embracing MBDD can significantly improve drug development success rates.
- Pharmaceutical companies must foster innovation and adapt to MBDD principles.
- Ultimately, patients benefit from more efficient and successful drug development through MBDD.
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