Hoffman David, Kringle Robert
Preclinical and Research Biostatistics, Sanofi-aventis, Bridgewater, New Jersey, USA.
Pharm Res. 2007 Jun;24(6):1157-64. doi: 10.1007/s11095-007-9242-3. Epub 2007 Mar 21.
Typical acceptance criteria for analytical methods are not chosen with regard to the concept of method suitability and are commonly based on ad-hoc rules. Such approaches yield unknown and uncontrolled risks of accepting unsuitable analytical methods and rejecting suitable analytical methods. This paper proposes a formal statistical framework for the validation of analytical methods, which incorporates the use of total error and controls the risks of incorrect decision-making.
A total error approach for method validation based on the use of two-sided beta-content tolerance intervals is proposed. The performance of the proposed approach is compared to the performance of current ad-hoc approaches via simulation techniques.
The current ad-hoc approaches for method validation fail to control the risk of incorrectly accepting unsuitable analytical methods. The proposed total error approach controls the risk of incorrectly accepting unsuitable analytical methods and provides adequate power to accept truly suitable methods.
Current ad-hoc approaches to method validation are inconsistent with ensuring method suitability. A total error approach based on the use of two-sided beta-content tolerance intervals was developed. The total error approach offers a formal statistical framework for assessing analytical method performance. The approach is consistent with the concept of method suitability and controls the risk of incorrectly accepting unsuitable analytical methods.
分析方法的典型验收标准并非根据方法适用性概念来选择，通常基于临时规则。此类方法在接受不合适的分析方法以及拒绝合适的分析方法方面会产生未知且不受控制的风险。本文提出了一个用于分析方法验证的正式统计框架，该框架纳入了总误差的使用并控制错误决策的风险。
提出了一种基于双侧贝塔含量容忍区间使用的方法验证总误差方法。通过模拟技术将所提出方法的性能与当前临时方法的性能进行比较。
当前用于方法验证的临时方法无法控制错误接受不合适分析方法的风险。所提出的总误差方法控制了错误接受不合适分析方法的风险，并为接受真正合适的方法提供了足够的效力。
当前用于方法验证的临时方法与确保方法适用性不一致。开发了一种基于双侧贝塔含量容忍区间使用的总误差方法。总误差方法为评估分析方法性能提供了一个正式的统计框架。该方法与方法适用性概念一致，并控制了错误接受不合适分析方法的风险。
