1010 USP39-NF34 ANALYTICAL DATA INTERPRETATION AND TREATMENT£¨ÖÐÓ¢ÎÄ£© ÏÂÔØ±¾ÎÄ

value and the resulting differences are divided by MAD (see below). The calculation of MAD is done in three stages. First, the median is subtracted from each data point. Next, the absolute values of the differences are obtained. These are called the absolute deviations. Finally, the median of the absolute deviations is calculated and multiplied by the constant 1.483 to obtain MAD6.

½×¶Î1¡ªÓ¦ÓÃHampel¹æÔòµÄµÚÒ»²½Êǽ«Êý¾ÝÕý̬»¯¡£È»¶ø£¬²»ÊÇʹÓý«Ã¿¸öÊý¾Ý¼õȥƽ¾ùÖµºóÔÙ³ýÒÔ±ê׼ƫ²î£¬¶øÊǽ«Ã¿¸öÊý¾Ý¼õÈ¥ÖÐλֵºóÓòîÖµ³ýÒÔMAD£¨²Î¼ûÏÂÎÄ£©¡£MADµÄ¼ÆËãÓÐ3¸ö²½Öè¡£Ê×ÏÈ£¬Ã¿¸öÊý¾Ý¼õÈ¥ÖÐλֵ¡£È»ºó£¬È¡²îÖµµÄ¾ø¶ÔÖµ¡£ÕâЩֵ±»³ÆÎª¾ø¶ÔÆ«²î¡£×îºó£¬¼ÆËã¾ø¶ÔÆ«²îµÄÖÐλֵ£¬ÔÙ³ËÒÔ³£Êý1.483À´µÃµ½MAD6¡£

Step 2¡ªThe second step is to take the absolute value of the normalized data. Any such result that is greater than 3.5 is declared to be an outlier. Table 4 summarizes the calculations.

½×¶Î2¡ªµÚ¶þ¸ö²½ÖèÊǼÆËãÕý̬»¯Êý¾ÝµÄ¾ø¶ÔÖµ¡£Èκγ¬¹ýÁË3.5µÄ½á¹û¶¼±»Ê¶±ðΪÒì³£Öµ¡£±í4»ã×ÜÁ˼ÆËã¡£ The value of 95.7 is again identified as an outlier. This value can then be removed from the data set and Hampel's Rule reapplied to the remaining data. The resulting table is displayed as Table 5. Similar to the previous examples, 99.5 is not considered an outlier.

95.7Ôٴα»Ê¶±ðΪÒì³£Öµ¡£Õâ¸öÖµ¿ÉÒÔ´ÓÊý¾Ý×éÖгýÈ¥£¬¶ÔÊ£ÓàÊýÖµÔÙ´ÎÓ¦ÓÃHampel¹æÔò¡£¼ÆËã½á¹ûÏÔʾÔÚ±í5µ±ÖС£ÓëÇ°ÃæµÄÀý×ÓÏàͬ£¬99.5δ±»Ê¶±ðΪÒì³£Öµ¡£

Table 4. Test Results Using Hampel's Rule

Median = MAD = Data 100.3 100.2 100.1 100 100 100 99.9 99.7 99.5 95.7 100 n = 10 Deviations from the Median 0.3 0.2 0.1 0 0 0 ?0.1 ?0.3 ?0.5 ?4.3 Absolute Deviations 0.3 0.2 0.1 0 0 0 0.1 0.3 0.5 4.3 0.15 0.22 Absolute Normalized 1.35 0.90 0.45 0 0 0 0.45 1.35 2.25 19.33

Table 5. Test Results of Re-Applied Hampel's Rule

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Assuming an underlying normal distribution, 1.483 is a constant used so that the resulting MAD is a consistent estimator of the population standard deviation.This means that as the sample size gets larger, MAD gets closer to the population standard deviation.

¼Ù¶¨Ò»¸öDZÔÚµÄÕý̬·Ö²¼£¬1.483×÷Ϊ³£ÊýʹÓ㬿ÉÒÔʹµÃµ½µÄMAD¾ÍÊÇ×ÜÌå±ê׼ƫ²îµÄÒ»Ö¹À¼ÆÖµ¡£ÕâÒâζ×ÅËæ×ÅÑù±¾ÊǵÄÔö¼Ó£¬MAD¸ü¼ÓÇ÷½üÓÚ×ÜÌåµÄ±ê׼ƫ²î¡£

Median = MAD = Data 100.3 100.2 100.1 100 100 100 99.9 99.7 99.5 100 n = 9 Deviations from the Median Absolute Deviations Absolute Normalized 0.3 0.3 2.02 0.2 0.2 1.35 0.1 0.1 0.67 0 0 0 0 0 0 0 0 0 ?0.1 0.1 0.67 ?0.3 0.3 2.02 ?0.5 0.5 3.37 0.1 0.14

APPENDIX D: COMPARISON OF PROCEDURES¡ªPRECISION

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The following example illustrates the calculation of a 90% confidence interval for the ratio of (true) variances for the purpose of comparing the precision of two procedures. It is assumed that the underlying distribution of the sample measurements are well-characterized by normal distributions. For this example, assume the laboratory will accept the alternative procedure if its precision (as measured by the variance) is no more than four-fold greater than that of the current procedure.

ΪÁ˱ȽÏÁ½ÖÖ·½·¨µÄ¾«ÃܶÈÐèÒª¼ÆËã£¨Õæ£©·½²î±ÈÖµµÄ90%ÖÃÐÅÇø¼ä£¬ÏÂÃæµÄʵÀý²ûÊöÁ˼ÆËã¹ý³Ì¡£ÐèÒª¼ÙÉèÑù±¾²âÁ¿ÖµµÄ·Ö²¼±¾ÖÊÉÏÊÇÁ¼ºÃµÄÕý̬·Ö²¼¡£¶ÔÓÚ±¾Àý£¬Èç¹ûÌæ´ú·½·¨µÄ¾«Ãܶȣ¨ÒÔ·½²î¼ÆË㣩²»´óÓÚÏÖÐз½·¨µÄ4±¶£¬ÊµÑéÊҾͿÉÒÔ½ÓÊÜÌæ´ú·½·¨¡£

To determine the appropriate sample size for precision, one possible method involves a trial and error approach using the following formula:

¶ÔÓÚ¾«ÃܶÈʵÑéÐèҪȷ¶¨Êʵ±µÄÑù±¾Á¿£¬Ê¹ÓÃÏÂÁй«Ê½µÄÊÔ´í·¨ÊÇÒ»ÖÖ¿ÉÄܵÄÈ·¶¨·½·¨£º

where n is the smallest sample size required to give the desired power, which is the likelihood of correctly claiming the alternative procedure has acceptable precision when in fact the two procedures have equal precision; ¦Á is the risk of wrongly claiming the alternative procedure has acceptable precision; and the 4 is the allowed upper limit for an increase in variance. F-values are found in commonly available tables of critical values of the F-distribution. F¦Á, n-1, n-1 is the upper a percentile of an F-distribution with n-1 numerator and n-1 denominator degrees of freedom; that is, the value exceeded with probability¦Á. Suppose initially the laboratory guessed a sample size of 11 per procedure was necessary (10 numerator and denominator degrees of freedom); the power calculation would be as follows7:

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Pr [F>/4F¦Á, n-1, n-1] = Pr [F>/4F.05, 10, 10] = Pr [F> (2.978/4)] = 0.6751

In this case the power was only 68%; that is, even if the two procedures had exactly equal variances, with only 11

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This could be calculated using a computer spreadsheet. For example, in Microsoft? Excel the formula would be:

FDIST((R/A)*FINV(alpha, n ? 1, n ? 1), n ? 1, n ? 1), where R is the ratio of variances at which to determine power (e.g., R = 1, which was the value chosen in the power calculations provided in Table 6) and A is the maximum ratio for acceptance (e.g., A = 4). Alpha is the significance level, typically 0.05.

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samples per procedure, there is only a 68% chance that the experiment will lead to data that permit a conclusion of no more than a fourfold increase in variance. Most commonly, sample size is chosen to have at least 80% power, with choices of 90% power or higher also used. To determine the appropriate sample size, various numbers can be tested until a probability is found that exceeds the acceptable limit (e.g., power >0.90). For example, the power determination for sample sizes of 12¨C20 are displayed in Table 6. In this case, the initial guess at a sample size of 11 was not adequate for comparing precision, but 15 samples per procedure would provide a large enough sample size if 80% power were desired, or 20 per procedure for 90% power.

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Table 6. Power Determinations for Various Sample Sizes (Specific to the Example in Appendix D) (Continued)

Typically the sample size for precision comparisons will be larger than for accuracy comparisons. If the sample size for precision is so large as to be impractical for the laboratory to conduct the study, there are some options. The first is to reconsider the choice of an allowable increase in variance. For larger allowable increases in variance, the required sample size for a fixed power will be smaller. Another alternative is to plan an interim analysis at a smaller sample size, with the possibility of proceeding to a larger sample size if needed. In this case, it is strongly advisable to seek professional help from a statistician.

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Now, suppose the laboratory opts for 90% power and obtains the results presented in Table 7 based on the data generated from 20 independent runs per procedure.

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