
------------------ stab for R v0.1.8 ------------------

 developed by Hsin-ya Lee and Yung-jin Lee, 2007-2013.
 This report was generated on Wed Dec 11 02:26:17 2013 


<< --- List of input data --- >>

   batch time assay
1      1    0  98.4
2      1    3  96.1
3      1    6  94.2
4      1    9  93.5
5      1   12  90.0
6      1   18  89.1
7      1   24  89.2
8      1   36  87.3
9      2    0  99.1
10     2    3  97.2
11     2    6  96.3
12     2    9  95.2
13     2   12  93.4
14     2   18  91.5
15     2   24  90.3
16     3    0 104.1
17     3    3 102.1
18     3    6  99.5
19     3    9  98.1
20     3   12  95.7
21     3   18  94.1
22     3   24  94.0
23     3   36  93.5


 Analysis settings for multiple batches:
 ---------------------------------------------
 The lower acceptance limit is set to 90 %.

<<Output: ANCOVA model: batch vs. time vs. assay (%)>>

Analysis of Variance Table

Response: assay
           Df  Sum Sq Mean Sq F value    Pr(>F)    
batch       2 117.410  58.705 21.6350 2.128e-05 ***
time        1 230.376 230.376 84.9025 5.067e-08 ***
batch:time  2   1.978   0.989  0.3645    0.6998    
Residuals  17  46.128   2.713                      
---
Signif. codes:  0 *** 0.001 ** 0.01 * 0.05 . 0.1   1


       Type     P values
1 Intercept 2.127905e-05
2     Slope 6.998373e-01
--------------------------
at a sig. level of 0.25.

--------------------------------------------------------------------------
          << ANCOVA Output: Testing for poolability of batches >>         
--------------------------------------------------------------------------
                                                                          
 The test rejects the hypothesis of equality of intercepts but fails to   
 reject that the slopes are equal (there is a significant difference in   
 intercepts but no significant difference in slopes among the batches).   
                                                                          
               <<Model #2: one-sided lower LC analysis>>                  
         separate intercepts with a common slope among batches.           
------------------------------------------------------------------------

              <<linear regression model: Assay (%) vs. time>>             

Call:
lm(formula = assay ~ batch + time, data = ANCOVAdata)

Coefficients:
(Intercept)       batch2       batch3         time  
    96.3686       1.5027       5.4125      -0.3069  

Analysis of Variance Table

Response: assay
          Df  Sum Sq Mean Sq F value    Pr(>F)    
batch      2 117.410  58.705  23.186 7.979e-06 ***
time       1 230.376 230.376  90.989 1.120e-08 ***
Residuals 19  48.106   2.532                      
---
Signif. codes:  0 *** 0.001 ** 0.01 * 0.05 . 0.1   1

**************************************************************************
                               << Output >>                               
--------------------------------------------------------------------------
                    <<Summary: linear regression model>>                

 --- Batch#: 1 ---

   Y (assay, %) = 96.36857 + ( -0.30693 )*Time

    Time  Obs. assay(%)  Calc. assay(%)  Residuals
1     0           98.4        96.36857 -2.0314274
2     3           96.1        95.44778 -0.6522213
3     6           94.2        94.52698  0.3269848
4     9           93.5        93.60619  0.1061909
5    12           90.0        92.68540  2.6853970
6    18           89.1        90.84381  1.7438091
7    24           89.2        89.00222 -0.1977787
8    36           87.3        85.31905 -1.9809543


-- List of 95 % CI for 84-month Time Interval:-

   time      fit    Lower star
1     0 96.36857 94.96301     
2     1 96.06164 94.74064     
3     2 95.75471 94.51630     
4     3 95.44778 94.28957     
5     4 95.14085 94.05992     
6     5 94.83392 93.82667     
7     6 94.52698 93.58897     
8     7 94.22005 93.34576     
9     8 93.91312 93.09577     
10    9 93.60619 92.83747     
11   10 93.29926 92.56921     
12   11 92.99233 92.28933     
13   12 92.68540 91.99648     
14   13 92.37847 91.68985     
15   14 92.07153 91.36943     
16   15 91.76460 91.03598     
17   16 91.45767 90.69085     
18   17 91.15074 90.33568     
19   18 90.84381 89.97215  ***
20   19 90.53688 89.60175  ***
21   20 90.22995 89.22581  ***
22   21 89.92302 88.84537  ***
23   22 89.61608 88.46130  ***
24   23 89.30915 88.07429  ***
25   24 89.00222 87.68485  ***
26   25 88.69529 87.29344  ***
27   26 88.38836 86.90037  ***
28   27 88.08143 86.50592  ***
29   28 87.77450 86.11032  ***
30   29 87.46756 85.71373  ***
31   30 87.16063 85.31630  ***
32   31 86.85370 84.91814  ***
33   32 86.54677 84.51936  ***
34   33 86.23984 84.12004  ***
35   34 85.93291 83.72023  ***
36   35 85.62598 83.32001  ***
37   36 85.31905 82.91943  ***
38   37 85.01211 82.51851  ***
39   38 84.70518 82.11730  ***
40   39 84.39825 81.71583  ***
41   40 84.09132 81.31412  ***
42   41 83.78439 80.91220  ***
43   42 83.47746 80.51010  ***
44   43 83.17053 80.10781  ***
45   44 82.86360 79.70537  ***
46   45 82.55666 79.30279  ***
47   46 82.24973 78.90008  ***
48   47 81.94280 78.49724  ***
49   48 81.63587 78.09429  ***
50   49 81.32894 77.69125  ***
51   50 81.02201 77.28810  ***
52   51 80.71508 76.88487  ***
53   52 80.40814 76.48156  ***
54   53 80.10121 76.07818  ***
55   54 79.79428 75.67472  ***
56   55 79.48735 75.27121  ***
57   56 79.18042 74.86763  ***
58   57 78.87349 74.46399  ***
59   58 78.56656 74.06030  ***
60   59 78.25963 73.65656  ***
61   60 77.95269 73.25278  ***
62   61 77.64576 72.84895  ***
63   62 77.33883 72.44508  ***
64   63 77.03190 72.04117  ***
65   64 76.72497 71.63723  ***
66   65 76.41804 71.23325  ***
67   66 76.11111 70.82924  ***
68   67 75.80418 70.42520  ***
69   68 75.49724 70.02112  ***
70   69 75.19031 69.61703  ***
71   70 74.88338 69.21290  ***
72   71 74.57645 68.80875  ***
73   72 74.26952 68.40458  ***
74   73 73.96259 68.00038  ***
75   74 73.65566 67.59616  ***
76   75 73.34873 67.19193  ***
77   76 73.04179 66.78767  ***
78   77 72.73486 66.38339  ***
79   78 72.42793 65.97910  ***
80   79 72.12100 65.57479  ***
81   80 71.81407 65.17047  ***
82   81 71.50714 64.76612  ***
83   82 71.20021 64.36177  ***
84   83 70.89327 63.95740  ***
85   84 70.58634 63.55301  ***

 ***: means the listing of expiration as defined.

 --- Batch#: 2 ---

   Y (assay, %) = 97.87129 + ( -0.30693 )*Time

    Time  Obs. assay(%)  Calc. assay(%)   Residuals
1     0           99.1        97.87129 -1.22870662
2     3           97.2        96.95050 -0.24950053
3     6           96.3        96.02971 -0.27029443
4     9           95.2        95.10891 -0.09108833
5    12           93.4        94.18812  0.78811777
6    18           91.5        92.34653  0.84652997
7    24           90.3        90.50494  0.20494217


-- List of 95 % CI for 84-month Time Interval:-

   time      fit    Lower star
1     0 97.87129 95.90047     
2     1 97.56436 95.72657     
3     2 97.25743 95.55069     
4     3 96.95050 95.37234     
5     4 96.64357 95.19086     
6     5 96.33664 95.00536     
7     6 96.02971 94.81465     
8     7 95.72277 94.61708     
9     8 95.41584 94.41040     
10    9 95.10891 94.19162     
11   10 94.80198 93.95696     
12   11 94.49505 93.70204     
13   12 94.18812 93.42274     
14   13 93.88119 93.11641     
15   14 93.57426 92.78298     
16   15 93.26732 92.42501     
17   16 92.96039 92.04661     
18   17 92.65346 91.65213     
19   18 92.34653 91.24540     
20   19 92.03960 90.82946     
21   20 91.73267 90.40657     
22   21 91.42574 89.97840  ***
23   22 91.11880 89.54617  ***
24   23 90.81187 89.11078  ***
25   24 90.50494 88.67289  ***
26   25 90.19801 88.23301  ***
27   26 89.89108 87.79150  ***
28   27 89.58415 87.34867  ***
29   28 89.27722 86.90475  ***
30   29 88.97029 86.45990  ***
31   30 88.66335 86.01428  ***
32   31 88.35642 85.56800  ***
33   32 88.04949 85.12116  ***
34   33 87.74256 84.67382  ***
35   34 87.43563 84.22607  ***
36   35 87.12870 83.77794  ***
37   36 86.82177 83.32949  ***
38   37 86.51484 82.88075  ***
39   38 86.20790 82.43175  ***
40   39 85.90097 81.98253  ***
41   40 85.59404 81.53311  ***
42   41 85.28711 81.08350  ***
43   42 84.98018 80.63372  ***
44   43 84.67325 80.18380  ***
45   44 84.36632 79.73374  ***
46   45 84.05938 79.28356  ***
47   46 83.75245 78.83327  ***
48   47 83.44552 78.38288  ***
49   48 83.13859 77.93239  ***
50   49 82.83166 77.48181  ***
51   50 82.52473 77.03115  ***
52   51 82.21780 76.58042  ***
53   52 81.91087 76.12962  ***
54   53 81.60393 75.67876  ***
55   54 81.29700 75.22784  ***
56   55 80.99007 74.77687  ***
57   56 80.68314 74.32584  ***
58   57 80.37621 73.87477  ***
59   58 80.06928 73.42365  ***
60   59 79.76235 72.97249  ***
61   60 79.45542 72.52129  ***
62   61 79.14848 72.07005  ***
63   62 78.84155 71.61878  ***
64   63 78.53462 71.16748  ***
65   64 78.22769 70.71615  ***
66   65 77.92076 70.26479  ***
67   66 77.61383 69.81340  ***
68   67 77.30690 69.36198  ***
69   68 76.99996 68.91054  ***
70   69 76.69303 68.45908  ***
71   70 76.38610 68.00759  ***
72   71 76.07917 67.55609  ***
73   72 75.77224 67.10456  ***
74   73 75.46531 66.65302  ***
75   74 75.15838 66.20146  ***
76   75 74.85145 65.74988  ***
77   76 74.54451 65.29828  ***
78   77 74.23758 64.84667  ***
79   78 73.93065 64.39505  ***
80   79 73.62372 63.94341  ***
81   80 73.31679 63.49176  ***
82   81 73.00986 63.04009  ***
83   82 72.70293 62.58841  ***
84   83 72.39600 62.13672  ***
85   84 72.08906 61.68502  ***

 ***: means the listing of expiration as defined.

 --- Batch#: 3 ---

   Y (assay, %) = 101.78107 + ( -0.30693 )*Time

    Time  Obs. assay(%)  Calc. assay(%)  Residuals
1     0          104.1       101.78107 -2.3189274
2     3          102.1       100.86028 -1.2397213
3     6           99.5        99.93948  0.4394848
4     9           98.1        99.01869  0.9186909
5    12           95.7        98.09790  2.3978970
6    18           94.1        96.25631  2.1563091
7    24           94.0        94.41472  0.4147213
8    36           93.5        90.73155 -2.7684543


-- List of 95 % CI for 84-month Time Interval:-

   time       fit     Lower star
1     0 101.78107 100.17274     
2     1 101.47414  99.97000     
3     2 101.16721  99.76538     
4     3 100.86028  99.55843     
5     4 100.55335  99.34859     
6     5 100.24642  99.13508     
7     6  99.93948  98.91691     
8     7  99.63255  98.69276     
9     8  99.32562  98.46089     
10    9  99.01869  98.21915     
11   10  98.71176  97.96493     
12   11  98.40483  97.69544     
13   12  98.09790  97.40821     
14   13  97.79097  97.10171     
15   14  97.48403  96.77589     
16   15  97.17710  96.43223     
17   16  96.87017  96.07320     
18   17  96.56324  95.70157     
19   18  96.25631  95.31995     
20   19  95.94938  94.93054     
21   20  95.64245  94.53508     
22   21  95.33552  94.13490     
23   22  95.02858  93.73103     
24   23  94.72165  93.32422     
25   24  94.41472  92.91507     
26   25  94.10779  92.50403     
27   26  93.80086  92.09143     
28   27  93.49393  91.67756     
29   28  93.18700  91.26262     
30   29  92.88006  90.84678     
31   30  92.57313  90.43019     
32   31  92.26620  90.01294     
33   32  91.95927  89.59514  ***
34   33  91.65234  89.17686  ***
35   34  91.34541  88.75815  ***
36   35  91.03848  88.33908  ***
37   36  90.73155  87.91968  ***
38   37  90.42461  87.50000  ***
39   38  90.11768  87.08006  ***
40   39  89.81075  86.65989  ***
41   40  89.50382  86.23952  ***
42   41  89.19689  85.81897  ***
43   42  88.88996  85.39825  ***
44   43  88.58303  84.97738  ***
45   44  88.27610  84.55638  ***
46   45  87.96916  84.13525  ***
47   46  87.66223  83.71401  ***
48   47  87.35530  83.29266  ***
49   48  87.04837  82.87122  ***
50   49  86.74144  82.44970  ***
51   50  86.43451  82.02809  ***
52   51  86.12758  81.60641  ***
53   52  85.82064  81.18466  ***
54   53  85.51371  80.76284  ***
55   54  85.20678  80.34097  ***
56   55  84.89985  79.91904  ***
57   56  84.59292  79.49706  ***
58   57  84.28599  79.07503  ***
59   58  83.97906  78.65295  ***
60   59  83.67213  78.23083  ***
61   60  83.36519  77.80868  ***
62   61  83.05826  77.38649  ***
63   62  82.75133  76.96426  ***
64   63  82.44440  76.54200  ***
65   64  82.13747  76.11970  ***
66   65  81.83054  75.69738  ***
67   66  81.52361  75.27503  ***
68   67  81.21668  74.85266  ***
69   68  80.90974  74.43026  ***
70   69  80.60281  74.00784  ***
71   70  80.29588  73.58539  ***
72   71  79.98895  73.16293  ***
73   72  79.68202  72.74044  ***
74   73  79.37509  72.31793  ***
75   74  79.06816  71.89541  ***
76   75  78.76123  71.47287  ***
77   76  78.45429  71.05031  ***
78   77  78.14736  70.62774  ***
79   78  77.84043  70.20515  ***
80   79  77.53350  69.78255  ***
81   80  77.22657  69.35993  ***
82   81  76.91964  68.93731  ***
83   82  76.61271  68.51466  ***
84   83  76.30577  68.09201  ***
85   84  75.99884  67.66935  ***

 ***: means the listing of expiration as defined.

**************************************************************************
                       << Summary and plots >>                            
--------------------------------------------------------------------------


  One-sided lower LC analysis                        

   batch#   shelf-life*
1       1            17
2       2            20
3       3            31
-------------------------
*: estimated shelf-life


 Ps. When shelf-life = 84, it means that stab
 cannot find a reasonable shelf-life for the
 batch with presented dataset within 84 months.

 -----------------------------------------------------------------

 Drug product with lower acceptance limit of 90 % of label claimed
 shelf-life = 17 (months)                          

******************************************************************

