Bioanalytical Method Development Strategies
Posted on Tue, Jul 12, 2011 @ 10:44 AM
Bioanalytical Method Development Challenges
Development of bioanalytical methods is essential for any drug development programme and it’s one area where delays often occur, but with a proper strategy in place this can be avoided.
Analytical method development is a discipline that requires:
- A clear understanding of the task to ensure the most appropriate technologies are applied.
- A systematic approach to optimising a large number of synergistic parameters.
- Clear logical thinking to investigate where there is less than optimal performance.
This is an involved, iterative and time consuming process with knowledge and experience being critical to success. With demanding delivery deadlines method development becomes a challenging phase of any project.
The success of method development can be due to scientists’ experience and knowledge of applicable regulatory guidelines. Laboratories that have limited experience in developing methods for bioanalysis in preclinical or clinical studies may not appreciate or be completely aware of the requirements of a fully validated method, or have the relevant experience to resolve common issues that can arise.
Bioanalytical Method Development Strategies
Quotient Bioresearch has long recognised the importance of method development in delivering the highest quality service. To find out the benefits of our bioanalytical method development strategy download a copy of the white paper