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Methods for Presenting Real-world Objects Under Controlled Laboratory Conditions
Published on: June 21, 2019
Reality in the 1990s and beyond-more with less
1Director Analytical Research and Development R.W. Johnson Pharmaceutical Research Institute Raritan New Jersey USA.
The pharmaceutical industry faces significant changes, requiring analytical labs to optimize resources. Strategies like laboratory automation and external support are crucial for navigating new regulatory demands and economic pressures.
Area of Science:
- Pharmaceutical industry
- Analytical chemistry
- Regulatory science
Background:
- The pharmaceutical sector is experiencing transformative changes due to managed care and pricing pressures.
- This has led to resource constraints and strategic re-evaluations within companies.
- Analytical laboratories face increased demands with fewer resources.
Purpose of the Study:
- To examine the impact of current industry realities on analytical support for new drug development.
- To explore strategies for optimizing resource allocation in analytical laboratories.
- To analyze the interplay between various resource management elements.
Main Methods:
- Qualitative analysis of industry trends and regulatory influences.
- Review of strategic approaches in pharmaceutical analytical laboratories.
- Discussion of resource optimization tactics.
Main Results:
- Key industry realities influencing analytical support include pre-approval inspections, the Barr decision, and proposed ICH guidelines.
- Laboratory automation, contract laboratories, consultants, and temporary staff are common strategies for resource optimization.
- Each strategy presents unique advantages and disadvantages.
Conclusions:
- Adaptation to the evolving pharmaceutical landscape requires strategic resource management in analytical laboratories.
- Integrating automation and external support services can help address the 'do more with less' challenge.
- A comprehensive understanding of these factors is essential for successful product development.
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