Question 2

A batch of the anti-bacterial drug Nitrofurantoin has been checked to ensure the drug
content is within specification, which is 100 mg +/- 10 % w/w in the tablet.

a) Given the results from the analysis below, and using the appropriate statistical tests, what
is the 95% confidence interval for the true Nitrofurantoin content of the tablet, and does the
batch of drugs pass the specification?

Write down the equations you use, defining the variables in those equations. Explain the
steps in your calculation for full marks.

(80% of the marks)

Replicate mg Nitrofurantoin
1 97.2
2 101.2
3 99.9
4 111.8 outlier
5 98.0
6 96.1

a)
First of all, we need to identify any outliers, 100 mg +/- 10 is between the range 90mg-
110mg, as this indicate 111.8 could be an outlier. To confirm this, we could also
apply Q test. Q test= [suspect value-nearest value/largest value-smallest value] =
[111.8-101.2/111.8-96.1]=0.675

From the tables at n=6 95%CL Qcrit=0.625.

Q calc >Q crit this means 111.8 is an outlier so it should be removed.

This question requires to find out confident intervals at 95% use equation:

Confidence Interval (95%) = mean ± (t x SEM) - where t is the value from the t distribution table at
4.d.f. 95% CL and SEM is the standard error of the mean which is the ‘standard deviation divides by
the square root of ‘n’ (number of replicates)’

t= 2.78 (4d.f at 95%CL)

X=mean=98.48mg,

S=standard deviation=2.058mg,
n=5 (number of replicate)

SEM=SD/ √n = 2.058/√5 =0.920

Confidence interval (95%) =98.48 ± (2.78x0.920) =98.48±2.5576mg which is between 95.92 mg-
101.04mg. Only replicates 4 does not pass the specification, other replicates in the table are
within the range which means they are pass the specification.

b) In your own words, explain why we use the confidence interval to determine the “true”
average weight of Nitrofurantoin in the batch of tablets, rather than just quoting the average
analysis weight and the standard deviation of that weight?

Samples is only a selection of the object from the population, thus different sample of the
same population will give the same results, this is referred to sampling error or variation due
to sampling. A mean derived from a sample is unlikely to be perfect estimate of the
population mean. As it is not possible to produce a single reliable value. The mean only
provides approximate mean of the population thus cause an issue with how well the sample
statistic estimates the underlying population values. Confidence interval enables us to quote
a range within which we are reasonably confident the true population mean lies, it provides a
range of values bounded above and below the statistic’s mean, which is likely to contain the
population parameter of the interest, thus it is used to indicate the reliability of an estimate.
We use standard error (SEM)instead of standard deviation (SD) because SD only indicates
how accurately the mean represents sample date, whereas SEM includes statistical
interference based on the sampling distribution, SEM is the SD of the theoretical distribution
of the sample means.