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Bioanalytical method transfer considerations of chromatographic-based assays
1inVentiv Health, 301D College Road East, Princeton, NJ 08540, USA.
Bioanalysis
|June 10, 2016
Summary
Outsourcing bioanalytical methods is key for efficient drug development. This involves transferring chromatographic assays between labs, requiring careful consideration for successful therapy delivery.
Area of Science:
- Pharmaceutical Science
- Drug Development
- Bioanalysis
Background:
- Bioanalysis is integral to modern drug development.
- Outsourcing bioanalytical methods is a common strategy.
- Method transfer between laboratories is crucial for efficient drug delivery.
Purpose of the Study:
- To discuss considerations for transferring bioanalytical methods.
- To focus on chromatographic-based assays.
- To address challenges in pharmaceutical research and development.
Main Methods:
- Review of current practices in bioanalytical method transfer.
- Discussion of considerations for chromatographic assays.
- Analysis of outsourcing strategies in drug development.
Main Results:
- Method transfer is a critical step in drug development.
- Chromatographic assays require specific transfer considerations.
- Outsourcing enhances efficiency in delivering therapies.
Conclusions:
- Successful bioanalytical method transfer is vital for drug development.
- Careful planning is needed for transferring chromatographic assays.
- Outsourcing bioanalytical methods streamlines therapy delivery.
Keywords:
Contract Research Organization (CRO)Sponsorbioanalysisgood laboratory practices (GLPs)new chemical entity (NCE)More Related Videos
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