1.

Tests may be carried out and confidence intervals calculated for the intercept parameter ? ₀ using the summary statistics of Table 6.1, p 251. Test the hypothesis that ? ₀ = 100% using a significance level of 0.05. Calculate a 95% confidence interval for ? ₀. Interpret and relate the results of the two calculations.

2.

The data shown in Table 6.2 are the 24 hour percentage dissolution results for a drug product tested in a USP Type 1 dissolution apparatus. The analysis was carried out using a UV spectrophotometer. The data come from a stability monitoring programme - the product was stored at 25 C and 60% relative humidity and was measured at the six time points indicated in Table 6.2. Each test result is the mean of six replicates (though this is not relevant to your calculations).

• Draw a scatterplot of the data.

• Fit a least squares regression line to the data.

• Calculate a 95% confidence interval for the slope and interpret the interval.

• Is the slope statistically significantly different from zero?

• Calculate a 95% confidence interval for the intercept and interpret the interval.

• Is the intercept statistically significantly different from 100%?

1.

The test statistic to test the hypothesis that the true intercept is 100% is (101.159 - 100)/0.685 = 1.69. This is not statistically significant as the critical values for...