Method development at Cornerstone Analytical begins with a discussion with the client and a thorough understanding of:
- Project requirements
- Test material (sample)
- Desired analyte/test
- Product specifications
- Regulatory status
- Project timeline
With this information, Cornerstone Analytical will prepare a proposal outlining the project deliverables, timeline, proposed analytical technology and pricing.
Cornerstone Analytical will recommend a preferred methodology in the proposal. This recommendation is based on the experience of our analytical chemists, literature articles, book information, and/or manufacturer technical notes.
Initial Method Evaluation
Cornerstone Analytical will prepare a draft method and will implement it in our laboratory. The method will be given an initial evaluation for performance to judge its likelihood of passing all performance criteria in ICH Q2(R1). Click here to view more on ICH Q2(R1).
While the performance characteristics vary based on the test, Cornerstone Analytical typically evaluates the method for accuracy and precision at this step. Generally, this is done by analyzing triplicate preparations or triplicate matrix spikes for accuracy and precision (repeatability). If the method passes generally accepted performance criteria, then Cornerstone will continue on with the full suite of development testing.
Methods that fail this initial method evaluation can often be refined to improve the performance to an acceptable level. Sometimes however, after several iterations of this evaluation process, it becomes apparent that another approach is necessary.
Method Development Experiments
Experiments are designed to meet the validation requirements of ICH Q2(R1). These include checks for accuracy, precision, limits of detection and quantitation, specificity, linearity and range. We may also examine standard stability and robustness.
Method Development Report
The results of the experimentation are documented in a final development report.