Comparison of Analytical Procedures in Method Transfer and Bridging Experiments.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Method Validation

Background:

• Comparing analytical procedures is crucial for method transfer and updates.
• Current USP <1010> guidance uses separate accuracy and precision tests, which is problematic due to their interdependence.
• Determining acceptance criteria for method comparison is challenging.

Purpose of the Study:

• To propose a total error approach for comparing analytical procedures.
• To establish a single criterion based on an allowable out-of-specification (OOS) rate.
• To overcome the difficulties in allocating acceptance criteria between precision and bias.

Main Methods:

• A total error approach is proposed, utilizing a single criterion based on an allowable out-of-specification (OOS) rate.
• Computations can be performed using standard simulation software.
• Numerical examples are provided for four common experimental designs in method transfer studies.

Main Results:

• The total error approach simplifies the determination of acceptance criteria in method comparison studies.
• This approach effectively manages the interdependence of accuracy and precision.
• The proposed method allows for the calculation of an acceptable probability of passing for practical sample sizes.

Conclusions:

• The total error approach offers a more robust and practical method for comparing analytical procedures.
• It provides a unified criterion for method transfer, improving reliability.
• Recommendations are offered for setting appropriate criteria to ensure successful method transfers.