根据ICH Q2的分析程序验证的信心区间 (R2)

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:

Consider a curve representing sample data drawn randomly from a normally distributed population. One must construct confidence intervals to estimate or to test a claim regarding the population standard deviation. For example, a 95% confidence interval covers 95% of the area under the curve, and the remaining 5% is equally distributed on either side of the curve. To achieve such confidence intervals, one must determine the critical values. The critical values are simply the values separating the...

R chart, or range chart, is a fundamental tool in statistical process control used to monitor the variability within a process. It complements the X-bar (x̄) chart by focusing on the range of the data, rather than individual values, providing a clear picture of the process dispersion over time.
An R chart plots the range of subsets of measurements collected from a process. Each point on the chart represents the range—defined as the difference between the maximum and minimum...

A confidence interval is a better estimate of the population than a point estimate, as it uses a range of values from a sample instead of a single value.
Confidence intervals have confidence coefficients that are crucial for their interpretation. The most common confidence coefficients are 0.90, 0.95, and 0.99, which can be written as percentages–90%, 95%, and 99%, respectively.
Suppose a person calculates a confidence interval with a confidence coefficient of 0.95. In that case, they can...

A complete procedure to test a claim about population standard deviation or population variance is explained here.
The hypothesis testing for the claim of population standard deviation (or variance) requires the data and samples to be random and unbiased. The population distribution also must be normal. There is no specific requirement on the sample size as the estimation is based on the chi-square distribution.
As a first step, the hypothesis (null and alternative) concerning the claim about...

The confidence interval is the range of values around the mean that contains the true mean. It is expressed as a probability percentage. The interpretation of a 95% confidence interval, for instance, is that the statistician is 95% confident that the true mean falls within the interval. The upper and lower limits of this range are known as confidence limits. The confidence limits for the true mean are estimated from the sample's mean, the standard deviation, and the statistical factor...