
------------------ stab for R v0.1.5 -------------------

 developed by Hsin-ya Lee and Yung-jin Lee, 2007-2013.

 generated on Thu Apr 11 16:57:59 2013 


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

   batch time assay
1      1    0  99.2
2      1    3  97.1
3      1    6  96.1
4      1    9  95.2
5      1   12  93.8
6      1   18  93.1
7      1   24  92.4
8      2    0  98.7
9      2    3  97.0
10     2    6  96.2
11     2    9  95.1
12     2   12  94.2
13     2   18  93.3
14     3    0 102.5
15     3    3  98.9
16     3    6  97.1
17     3    9  95.6
18     3   12  94.1
19     3   18  93.1


 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  8.683   4.342   5.4055   0.01957 *  
time        1 94.715  94.715 117.9215 6.859e-08 ***
batch:time  2  8.101   4.051   5.0432   0.02392 *  
Residuals  13 10.442   0.803                       
---
Signif. codes:  0 *** 0.001 ** 0.01 * 0.05 . 0.1   1


       Type   P values
1 Intercept 0.01956915
2     Slope 0.02392274
--------------------------
at a sig. level of 0.25.

--------------------------------------------------------------------------
          << ANCOVA Output: Testing for poolability of batches >>         
--------------------------------------------------------------------------
                                                                          
 The test rejects the hypothesis of equality of slopes (there is a        
 significant difference in slopes and intercepts among batches).          
                                                                          
               <<Model #3: one-sided lower LC analysis>>                  
        separate intercepts and separate slopes between batches.          
------------------------------------------------------------------------

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


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

Coefficients:
(Intercept)       batch2       batch3         time  batch2:time  
   98.04611      0.06961      2.86389     -0.26976     -0.02595  
batch3:time  
   -0.23357  

Analysis of Variance Table

Response: assay
           Df Sum Sq Mean Sq  F value    Pr(>F)    
batch       2  8.683   4.342   5.4055   0.01957 *  
time        1 94.715  94.715 117.9215 6.859e-08 ***
batch:time  2  8.101   4.051   5.0432   0.02392 *  
Residuals  13 10.442   0.803                       
---
Signif. codes:  0 *** 0.001 ** 0.01 * 0.05 . 0.1   1

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



 --- Batch#: 1 ---


 --- Batch#: 1 ---

Y = 98.04611 +( -0.2697605 ) X


   Time  Observed assay(%)  Calculated assay(%)   Residuals
1     0               99.2             98.04611 -1.15389222
2     3               97.1             97.23683  0.13682635
3     6               96.1             96.42754  0.32754491
4     9               95.2             95.61826  0.41826347
5    12               93.8             94.80898  1.00898204
6    18               93.1             93.19042  0.09041916
7    24               92.4             91.57186 -0.82814371

   time      fit    Lower starred
1     0 98.04611 97.01794        
2     1 97.77635 96.81025        
3     2 97.50659 96.59983        
4     3 97.23683 96.38611        
5     4 96.96707 96.16839        
6     5 96.69731 95.94584        
7     6 96.42754 95.71750        
8     7 96.15778 95.48230        
9     8 95.88802 95.23915        
10    9 95.61826 94.98703        
11   10 95.34850 94.72519        
12   11 95.07874 94.45326        
13   12 94.80898 94.17134        
14   13 94.53922 93.87998        
15   14 94.26946 93.58008        
16   15 93.99970 93.27268        
17   16 93.72994 92.95889        
18   17 93.46018 92.63974        
19   18 93.19042 92.31613        
20   19 92.92066 91.98884        
21   20 92.65090 91.65851        
22   21 92.38114 91.32566        
23   22 92.11138 90.99071        
24   23 91.84162 90.65402        
25   24 91.57186 90.31585        
26   25 91.30210 89.97645     ***
27   26 91.03234 89.63598     ***
28   27 90.76257 89.29462     ***
29   28 90.49281 88.95247     ***
30   29 90.22305 88.60966     ***
31   30 89.95329 88.26626     ***
32   31 89.68353 87.92234     ***
33   32 89.41377 87.57798     ***
34   33 89.14401 87.23322     ***
35   34 88.87425 86.88811     ***
36   35 88.60449 86.54268     ***
37   36 88.33473 86.19697     ***
38   37 88.06497 85.85101     ***
39   38 87.79521 85.50483     ***
40   39 87.52545 85.15844     ***
41   40 87.25569 84.81187     ***
42   41 86.98593 84.46512     ***
43   42 86.71617 84.11823     ***
44   43 86.44641 83.77119     ***
45   44 86.17665 83.42403     ***
46   45 85.90689 83.07674     ***
47   46 85.63713 82.72935     ***
48   47 85.36737 82.38186     ***
49   48 85.09760 82.03428     ***
50   49 84.82784 81.68661     ***
51   50 84.55808 81.33886     ***
52   51 84.28832 80.99104     ***
53   52 84.01856 80.64315     ***
54   53 83.74880 80.29520     ***
55   54 83.47904 79.94719     ***
56   55 83.20928 79.59912     ***
57   56 82.93952 79.25100     ***
58   57 82.66976 78.90283     ***
59   58 82.40000 78.55461     ***
60   59 82.13024 78.20635     ***
61   60 81.86048 77.85805     ***
62   61 81.59072 77.50971     ***
63   62 81.32096 77.16134     ***
64   63 81.05120 76.81293     ***
65   64 80.78144 76.46449     ***
66   65 80.51168 76.11602     ***
67   66 80.24192 75.76752     ***
68   67 79.97216 75.41899     ***
69   68 79.70240 75.07044     ***
70   69 79.43263 74.72186     ***
71   70 79.16287 74.37326     ***
72   71 78.89311 74.02464     ***
73   72 78.62335 73.67599     ***
74   73 78.35359 73.32733     ***
75   74 78.08383 72.97864     ***
76   75 77.81407 72.62994     ***
77   76 77.54431 72.28122     ***
78   77 77.27455 71.93248     ***
79   78 77.00479 71.58373     ***
80   79 76.73503 71.23496     ***
81   80 76.46527 70.88618     ***
82   81 76.19551 70.53738     ***
83   82 75.92575 70.18857     ***
84   83 75.65599 69.83974     ***
85   84 75.38623 69.49090     ***




 --- Batch#: 2 ---


 --- Batch#: 2 ---

Y = 98.11571 +( -0.2957143 ) X


   Time  Observed assay(%)  Calculated assay(%)  Residuals
1     0               98.7             98.11571 -0.5842857
2     3               97.0             97.22857  0.2285714
3     6               96.2             96.34143  0.1414286
4     9               95.1             95.45429  0.3542857
5    12               94.2             94.56714  0.3671429
6    18               93.3             92.79286 -0.5071429

   time      fit    Lower starred
1     0 98.11571 97.40949        
2     1 97.82000 97.16947        
3     2 97.52429 96.92621        
4     3 97.22857 96.67878        
5     4 96.93286 96.42597        
6     5 96.63714 96.16633        
7     6 96.34143 95.89817        
8     7 96.04571 95.61985        
9     8 95.75000 95.33009        
10    9 95.45429 95.02842        
11   10 95.15857 94.71531        
12   11 94.86286 94.39204        
13   12 94.56714 94.06026        
14   13 94.27143 93.72163        
15   14 93.97571 93.37764        
16   15 93.68000 93.02947        
17   16 93.38429 92.67806        
18   17 93.08857 92.32411        
19   18 92.79286 91.96817        
20   19 92.49714 91.61063        
21   20 92.20143 91.25181        
22   21 91.90571 90.89194        
23   22 91.61000 90.53123        
24   23 91.31429 90.16980        
25   24 91.01857 89.80778     ***
26   25 90.72286 89.44525     ***
27   26 90.42714 89.08230     ***
28   27 90.13143 88.71898     ***
29   28 89.83571 88.35535     ***
30   29 89.54000 87.99144     ***
31   30 89.24429 87.62729     ***
32   31 88.94857 87.26293     ***
33   32 88.65286 86.89839     ***
34   33 88.35714 86.53368     ***
35   34 88.06143 86.16883     ***
36   35 87.76571 85.80384     ***
37   36 87.47000 85.43874     ***
38   37 87.17429 85.07353     ***
39   38 86.87857 84.70822     ***
40   39 86.58286 84.34283     ***
41   40 86.28714 83.97735     ***
42   41 85.99143 83.61181     ***
43   42 85.69571 83.24620     ***
44   43 85.40000 82.88053     ***
45   44 85.10429 82.51480     ***
46   45 84.80857 82.14902     ***
47   46 84.51286 81.78320     ***
48   47 84.21714 81.41733     ***
49   48 83.92143 81.05142     ***
50   49 83.62571 80.68547     ***
51   50 83.33000 80.31949     ***
52   51 83.03429 79.95348     ***
53   52 82.73857 79.58743     ***
54   53 82.44286 79.22136     ***
55   54 82.14714 78.85526     ***
56   55 81.85143 78.48913     ***
57   56 81.55571 78.12298     ***
58   57 81.26000 77.75681     ***
59   58 80.96429 77.39062     ***
60   59 80.66857 77.02441     ***
61   60 80.37286 76.65818     ***
62   61 80.07714 76.29194     ***
63   62 79.78143 75.92568     ***
64   63 79.48571 75.55940     ***
65   64 79.19000 75.19311     ***
66   65 78.89429 74.82680     ***
67   66 78.59857 74.46048     ***
68   67 78.30286 74.09415     ***
69   68 78.00714 73.72780     ***
70   69 77.71143 73.36145     ***
71   70 77.41571 72.99508     ***
72   71 77.12000 72.62871     ***
73   72 76.82429 72.26232     ***
74   73 76.52857 71.89592     ***
75   74 76.23286 71.52952     ***
76   75 75.93714 71.16311     ***
77   76 75.64143 70.79668     ***
78   77 75.34571 70.43026     ***
79   78 75.05000 70.06382     ***
80   79 74.75429 69.69737     ***
81   80 74.45857 69.33092     ***
82   81 74.16286 68.96447     ***
83   82 73.86714 68.59800     ***
84   83 73.57143 68.23153     ***
85   84 73.27571 67.86506     ***




 --- Batch#: 3 ---


 --- Batch#: 3 ---

Y = 100.91 +( -0.5033333 ) X


   Time  Observed assay(%)  Calculated assay(%)  Residuals
1     0              102.5               100.91      -1.59
2     3               98.9                99.40       0.50
3     6               97.1                97.89       0.79
4     9               95.6                96.38       0.78
5    12               94.1                94.87       0.77
6    18               93.1                91.85      -1.25

   time       fit    Lower starred
1     0 100.91000 99.09266        
2     1 100.40667 98.73266        
3     2  99.90333 98.36430        
4     3  99.40000 97.98520        
5     4  98.89667 97.59229        
6     5  98.39333 97.18177        
7     6  97.89000 96.74936        
8     7  97.38667 96.29077        
9     8  96.88333 95.80277        
10    9  96.38000 95.28410        
11   10  95.87667 94.73602        
12   11  95.37333 94.16177        
13   12  94.87000 93.56562        
14   13  94.36667 92.95187        
15   14  93.86333 92.32430        
16   15  93.36000 91.68599        
17   16  92.85667 91.03933        
18   17  92.35333 90.38614        
19   18  91.85000 89.72781     ***
20   19  91.34667 89.06538     ***
21   20  90.84333 88.39965     ***
22   21  90.34000 87.73125     ***
23   22  89.83667 87.06064     ***
24   23  89.33333 86.38820     ***
25   24  88.83000 85.71424     ***
26   25  88.32667 85.03898     ***
27   26  87.82333 84.36262     ***
28   27  87.32000 83.68532     ***
29   28  86.81667 83.00721     ***
30   29  86.31333 82.32840     ***
31   30  85.81000 81.64896     ***
32   31  85.30667 80.96899     ***
33   32  84.80333 80.28853     ***
34   33  84.30000 79.60765     ***
35   34  83.79667 78.92640     ***
36   35  83.29333 78.24481     ***
37   36  82.79000 77.56291     ***
38   37  82.28667 76.88074     ***
39   38  81.78333 76.19832     ***
40   39  81.28000 75.51568     ***
41   40  80.77667 74.83284     ***
42   41  80.27333 74.14981     ***
43   42  79.77000 73.46661     ***
44   43  79.26667 72.78326     ***
45   44  78.76333 72.09976     ***
46   45  78.26000 71.41613     ***
47   46  77.75667 70.73238     ***
48   47  77.25333 70.04852     ***
49   48  76.75000 69.36455     ***
50   49  76.24667 68.68049     ***
51   50  75.74333 67.99633     ***
52   51  75.24000 67.31209     ***
53   52  74.73667 66.62778     ***
54   53  74.23333 65.94339     ***
55   54  73.73000 65.25893     ***
56   55  73.22667 64.57441     ***
57   56  72.72333 63.88983     ***
58   57  72.22000 63.20519     ***
59   58  71.71667 62.52049     ***
60   59  71.21333 61.83575     ***
61   60  70.71000 61.15096     ***
62   61  70.20667 60.46613     ***
63   62  69.70333 59.78125     ***
64   63  69.20000 59.09634     ***
65   64  68.69667 58.41138     ***
66   65  68.19333 57.72639     ***
67   66  67.69000 57.04137     ***
68   67  67.18667 56.35632     ***
69   68  66.68333 55.67123     ***
70   69  66.18000 54.98611     ***
71   70  65.67667 54.30097     ***
72   71  65.17333 53.61580     ***
73   72  64.67000 52.93061     ***
74   73  64.16667 52.24539     ***
75   74  63.66333 51.56014     ***
76   75  63.16000 50.87488     ***
77   76  62.65667 50.18959     ***
78   77  62.15333 49.50429     ***
79   78  61.65000 48.81897     ***
80   79  61.14667 48.13362     ***
81   80  60.64333 47.44826     ***
82   81  60.14000 46.76288     ***
83   82  59.63667 46.07749     ***
84   83  59.13333 45.39208     ***
85   84  58.63000 44.70666     ***




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


                     One-sided lower LC analysis                        

   batch#   shelf-life*
1       1            24
2       2            23
3       3            17
-------------------------
*: 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 claim  
 shelf-life = 17 (months)                            

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

