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Outliers in Replicated Crossover Study [Outliers]

posted by pash413 - India, 2016-07-11 09:04  - Posting: # 16481
Views: 13,126

Hello All,
This is regarding outlier(s) observation in 2 treatment 2 sequence 4 period Replicated Crossover Study.

As per in the post, I have worked out outlier calculation on my data of 12 subjects.

Data:

Subject  Seq             PK Values     
                 A1      A2      B1      B2
 1      ABAB   1286.8  2469.1   259.9    69.8
 3      ABAB   2718.0   839.2  2521.4  1427.9
 6      ABAB   2094.3  1724.2  2448.7  2120.5
 8      ABAB   1611.2  1940.5  1777.9    58.1
 9      ABAB   1918.2  3773.1   411.5  2338.0
12      ABAB  29682.3  1405.9  3319.2  4370.1
 2      BABA   1543.0  1118.1  2327.8   149.2
 4      BABA   3690.7   952.7   902.7   996.5
 5      BABA   2364.1   782.6  1914.7  1789.8
 7      BABA   1279.1  1926.6   794.1  1135.5
10      BABA   3769.9  3190.9  3288.9  5244.2
11      BABA   1315.0  2088.0  1079.9   217.4


A1: Test Formulation first administration; B1: Reference Formulation first administration
A2: Test Formulation second administration; B2: Reference Formulation second administration.

Calculated Residuals:

Subject  Seq              Residuals     
               sShi     sSFhi    sDThi    sDRhi
 1      ABAB  -1.7575   1.9362  -1.0832   0.5320
 3      ABAB   0.2143  -1.3030   0.6589  -0.0029
 6      ABAB   0.5426  -1.2493  -0.2763  -0.3074
 8      ABAB  -1.0723   0.9247  -0.6391   2.0422
 9      ABAB   0.1487   0.1226  -1.1069  -1.6561
12      ABAB   1.9241  -0.4312   2.4466  -0.6078
 2      BABA  -0.8265  -0.1165  -0.1546   1.5592
 4      BABA  -0.1650  -0.2546   0.8297  -0.4815
 5      BABA   0.1115  -1.3952   0.5925  -0.3622
 7      BABA  -0.3054  -0.4608  -0.8524  -0.6670
10      BABA   1.4984  -1.2477  -0.3028  -0.7451
11      BABA  -0.7975   0.3769  -0.9027   0.7386


Above are Residual values for Subject Outlier, Subject by formulation Outlier, Test formulation outlier and Reference formulation Outlier respectively.

Grubb's Value 2.411559518

So, as Residual value of Subject 12, A1 (2.4466) is greater than Grubb's value 2.411559518, it can be considered as Outlier.

So, according to the suggested method in the paper above, is my calculation and result correct?


Edit: Tabulators changed to spaces and BBcoded; see also this post #6. [Helmut]

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