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Development of Analytical Methods

Development of Analytical Methods

An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...

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Comparison of Analytical Procedures in Method Transfer and Bridging Experiments.

Richard K Burdick¹

¹Burdick Statistical Consulting, LLC, 7783 Renegade Hill Drive, Colorado Springs, Colorado, 80923, U.S.A.. RickBASU@aol.com.

The AAPS Journal

|July 19, 2023

Summary

This summary is machine-generated.

This study introduces a total error approach for comparing analytical methods, simplifying criteria setting by focusing on an allowable out-of-specification (OOS) rate. This method enhances analytical method transfer studies by addressing the interdependence of accuracy and precision.

Keywords:

accuracy bias intermediate precision life cycle of an analytical procedure method transfer precision

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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.