Drug Bioequivalence Page: 29
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29
is assumed that the lot or batch of tablets from
which the sample of six was drawn is satisfactory.
Alternatively, if one or two of the initial six
tablets fail the test, then the test is repeated
on 12 additional tablets. The criterion of
acceptability is then that at least 16 of the total
of 18 tablets disintegrate completely within the
time specified. Table A summarizes the probability
that the sample will meet the specified requirements
as a function of the percentage of defective tablets
in the batch from which the sample is drawn.
Table A. Probability of Acceptance as Function
of Percentage of Defective Tablets
(Disintegration Test)
Percent Defective Probability of Acceptance
1% 995
5% .96
10% .79
20$% . 39
30% .15
40% .004
Thus, for example, batches of tablets of which 20%
are defective with regard to the disintegration
tests would pass the specified disintegration test
39% of the time. This test procedure offers a
high order of assurance of detecting defective
lots only if the lots contain at least 40%
defective tablets.
B. DISSOLUTION TEST
The USP and NF dissolution tests state that six
tablets initially are to be tested for dissolution
properties. If all six meet the specifications,
it is assumed that the batch from which the sample
is drawn is acceptable. If one or two units fail
to meet requirements, then the test is repeated on
six additional units. If the testing reaches this
point, at least 10 of the 12 units tested must meet
the requirements of the dissolution test in order
to comply with compendia standards. Table B
summarizes the probability of acceptance in this
test as a function of percentage of defective
tablets or dosage units in the batch from which
the sample is drawn.
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United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel. Drug Bioequivalence, report, July 1974; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39335/m1/32/: accessed April 23, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.