Discussion of results:
The average concentration of testosterone in the cream
is 0.099% whereas nominal is 0.1%. This is 99% accurate
with a standard deviation of 0.0005%. The
average concentration of progesterone in the cream is
4.31% whereas nominal is 4.3%. This is also 99% accurate
within a standard deviation of 0.015%.
The average concentrations of oestradiol,
testosterone and progesterone in each troche are 2.89mg,
2.73mg and 252.9mg respectively. Nominal concentrations
are 3mg, 3mg and 250mg. These levels are well within
permissible levels, averaging 96% accuracy. The respective
standard deviations are 0.07mg, 0.05mg and 4.2mg, averaging
a standard deviation of less than the 2%. The results
for the cream and the troche are well within permissible
limits.
Compounding Significance:
The significance of high accuracy is that it indicates
to us that there is minimal loss of actives during the
compounding process. Also, it indicates that our weighing
scales are of a suitable sensitivity for the compounding
being undertaken, and that they are calibrated correctly.
The significance of high precision is
that it indicates that we are homogenising or blending
the actives effectively. It means that our homogenisation
techniques are good and that we are consistent in our
work, avoiding fluctuations in concentration within
the one dose form being compounded.
Clinical Significance:
High accuracy is clinically significant as it ensures
that what we nominate to be the dose of a particular
active in a dose form is indeed the dose being delivered
– we are not over or under dosing.
High precision is clinically significant
as it ensures that all our actives are homogenised uniformly
throughout the dose form thus avoiding bolus doses and
unnecessary fluctuations in patient blood levels.
Clinically, high accuracy and high precision
are a prelude to better patient outcomes through more
stable blood or saliva levels.
Conclusion:
The sample troche and cream compounded at BioPharm’s
laboratory attained high to outstanding levels of accuracy
and precision, indicating exemplary compounding techniques
and high quality assurance levels. The results also
indicate that the equipment used at BioPharm is of a
suitably high standard.
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