Expediting the formulation development process with the aid of automated dissolution in analytical research and development
2001
Speeding Up Drug Development with Automation
publication
Evidence: moderate
Author Information
Author(s): Jon P. Sadowitz
Primary Institution: Barr Laboratories, Inc.
Hypothesis
Can automation in analytical research and development expedite the drug formulation process?
Conclusion
Automation has significantly reduced the time to market for drug products at Barr Laboratories.
Supporting Evidence
- Automation has allowed Barr to reduce the time from product launch to submission to just 6 months.
- Using automated dissolution workstations has increased the volume of information generated in a shorter time.
- Collaboration between departments has been key to speeding up the development process.
Takeaway
Using machines to help make and test new medicines can make the process much faster, helping people get their medicine sooner.
Methodology
The study discusses the use of automated dissolution workstations and statistical design models to streamline drug formulation and testing.
Limitations
Not all products can follow the accelerated timeline due to raw material availability and other manufacturing issues.
Digital Object Identifier (DOI)
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