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April 5, 2013
Contents
1. Brief introduction on sampling I. Methods of sampling 2. Probability distribution 3. Terms used 4. Parametric and Non Parametric methods 5. Parametric methods I. T test II. 2 test III. F test 6. Nonparametric methods I. Types of data II. Methods III. Sign test IV. Wilcoxon signed rank test V. Wilcoxon Rank sum test VI. Kruskal Wallis Test ( one way ANOVA) VII. Friedman test (two way ANOVA) VIII.Analysis of covariance IX. Run test for randomness X. Contingency tables 7. References
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Sampling plan
After selection of sample, plan should be made for approval. It may be single, double, multiple sampling.
Single Approving the lot by examining a single lot. Double Approving by examining the second lot where first lot dont meet requirements. Multiple Approving the lot by examining many lots till it satisfies the preset requirements. Eg Dissolution test Q limits.
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Methods of sampling
Methods of sampling
Random sampling Random sampling (each sample has equal opportunity) Random numbers Lottery method Stratified sampling Systematic sampling Non random sampling Judgement, purposive or deliberate
Quota
Convenience
Cluster sampling
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Probability distribution
Mathematical determination of frequency distribution.
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Terms used Significance is having difference between two compared samples or methods.
Level of significance Probability of making type 1 error here null hypothesis is rejected when it is true Different levels are 1%, 5%, 10% etc., mostly 5% is used. Mostly 5% level of significance is used (p = 0.05) Ranking, average ranking, geometric mean of ranks -
Different ranks are given for the data according to ascending or descending order. For values with same ranks average of ranks is given as common value. Geometric mean of values is given as Hypothesis
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Parametric methods
t - Test
Assessing the significance of difference is test of significance.
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Smaller samples
where
are means
Paired samples
where
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2 test
This test describes the magnitude of difference between observed frequency and expected frequency.
These differences are compared to the tabulated values to show significance Where f0 is observed frequency fe is expected frequency Degree of freedom Given by (c-1) or (c-1)x(r-1) Increase in the degree of freedom increases the symmetry of the curve
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Applications
Check the good fit. Check Independence of variables by contingency tables Test for homogenity Detection of linkage 11
F - test
This test is to check the equality of 2 variables from two populations. It is simply given as Where S1 and S2 are variances if not given directly in the data can be obtained by squaring standard deviation
With reference to ANOVA it is given as
Types of Data
1. Nominal/ Categoirical data categorized in to a particular group. Eg colours like white, Black, Yellow, Red,
Methods
1. 2. 3. 4. 5. 6. 7. 8. Sign Test WilcoXon Signed Rank Test Wilcoxon rank sum test Kruskal wallis test (one way ANOVA) Friedman test (two way ANOVA) Analysis of covariance Contingency tables Run test
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Sign test
It is the simplest of nonparametric tests This is compared to one sample t test of parametric tests.
Ex - Data from peak Plasma concentraion
Subject Time of peak plasma conc. (hr) A B 2.5 3.5 3.0 4.0 1.25 2.5 1.75 2.0 3.5 3.5 2.5 4.0 1.75 1.5 2.25 2.5 3.5 3.0 2.5 3.0 2.0 3.5 3.5 4.0 Difference (BA) +1 +1 +1.25 +0.25 0 +1.5 -0.25 +0.25 -0.5 +0.5 +1.5 +0.5
Steps
1. Calculate the difference of measurent of paired matches 2. Remove ties if any 3. Count the number of times one treatment has higher value. Number of positives or negatives. 4. Compare with tabulated values.
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Sign test
The values of Z for more than 20 samples can be obtained by normal approximation.
Where
It can be simplifies as
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Steps
1. Claculate difference 2. Ranks are asigned disregarding sign 3. Average ranks are given for same values 4. Reassign the signs to assigned ranks 5. Ranks with like sign are summed up
-0.25 0.25 0.25 -0.5 0.5 0.5 1.0 1.0 1.25 1.5 1.5
Assigned Rank Rank with sign 2 -2 2 2 2 2 5 -5 5 5 5 5 7.5 7.5 7.5 7.5 9 9 10.5 10.5 10.5 10.5
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Where
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Where
T is sum of ranks for small sample size N1 is small sample size N2 is large sample size
For the above data Z is obtained as 1.63 which is not more at 5% significance.(form significance table)
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Where
k-1 is degree of freedom k is number of groups N is total no of observations Ri is sum of ranks of ithgroup ni is number of observation in ith group
Chi-square is obtained as
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Example -
Different treatments
Sample 1 20 10 17 17 16 sample 2 19 13 17 12 9 sample 3 13 12 10 15 5
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Replicates
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Degree of freedom Sum of squares Mean of squares c-1(n1) B-D B-D/c-1 c(r-1) (n2) cr-1 A-B A-D A-B/c(r-1)
24
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1. Unlike rank sum test the ranks are given to individual groups i.e., with in the group. 2. If there are ties average ranks are given. 3. Test for significance is obtained by chi-square distribuiton
Tablet formulation 1 2 3 4 5 Ri
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Tablet press A 7.5(4) 8.2(3) 7.3(1) 6.6(3) 7.5(3) 14 B 637(1) 8.0(2) 7.9(3) 6.5(2) 6.8(2) 10 C 7.3(3) 8.5(4) 8.0(4) 7.1(4) 7.6(4) 19 D 7.0(2) 7.9(1) 7.6(2) 6.7(1) 6.7(1) 7
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Where
c is number of column c-1 is degree of freedom r is number of rows Ri is sum of ranks in Ith group
The value of chi-square for the above data is 9.72 At the level of 5% significance chi-square value is high and the tablet press shows significant differences
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Example
Yields of different variety of rice and four nitrogen rates were recorded. Different treatments
Nitrogen rate (Kg/ha) 0 30 60 90 v1 4.50 4.30 5.60 5.21 19.61
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Replicates
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Source of variation Between treatments (column) Between replicates (rows) Residual (row) Total
Calculated F value for the given data is between varieties 25.34, between treatments is 14.38 F values for treatments i.e., different varieties has significance, for nitrogen fretilizer it is below the tabulateed value and has no significance.
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Analysis of covariance
Steps involved 1. 2. 3. 4.
Rank X, Y irrespective of their treatments. Correct ranks to get mean of ranks 0. Perform regression for all data (predicted value) Residual is calculated (observed predicted) i.e., Ry-predicted
raw material X 98.40 98.6 98.6 99.2 Ranks RY 2.50 1.50 3.50 -0.5 RX -3.0 -1.0 -1.0 2.50 predicted 1.445 0.481 0.481 -1.204 Residual 1.0548 1.0182 3.0182 0.7042 5.7957 0.7408 -2.7774 -3.4451 -5.7957
Final assay Y Method 1 98.0 97.80 98.5 97.4 sum Method 2 97.6 95.4 96.1 sum
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Ex 6 tablets with weight of >200 mg, next 5 tablets with weight of < 200 mg, next 4 tablets with weight of > 200 mg, next 5 tablets with weight of < 200 mg, etc.,
In this method compare the number of runs with the tabulated values, upper limits are checked for measuring significance.
If the sample size if greater than 40 then significance is calculated by normal approximation using the formula
Where r is number of runs
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Contingency tables
This is used for categorical data which cant be analyzed by Ranking methods, R X C is rows X columns The relationship in rows and columns in contingency is given by chi-square method with (R-1)(C-1) as degree of freedom
Estimated values are obtained from product of row sum, column sum, and dividing by grand total.
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Data
Very severe
Treatment A Treatment B Total 13 19 32
moderately severe
24 20 44
mildly severe
18 12 30
Total
55 51 106
Expected values
Very severe
Treatment A Treatment B Total 16.60 15.40 32
moderately severe
22.83 21.17 44
mildly severe
15.57 14.43 30
Total
55 51 106
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Thank You
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References:
1. Khan and Khanum, Fundamentals of Biostatistics, third edition, 2009. 2. Sanford Bolton, Charles BON, Pharmaceutical Statistics practical and clinical applicatrions, fourth edition,
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First samples need to be collected , analysed by appropriate method and then the data is made to fit in to any of the frequecy curves, or to different distribuiton which is appropriate, then from different methds the samples are characterized like parametric methods, non parametric methods, control charts, from these methods you can find whether the samples or data shows significance or not from control chart limits.