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This replication tends to reduce the systematic accumulation of errors, as well as the introduction of spurious ones To further reduce spurious errors, two photographic plates may be measured and reduced in this fashion, and the results of the two tests may be averaged together This reduces errors due to imperfect photographic emulsions and nonrandom air turbulence between mirror and plate, as well as measuring errors 1043 Southwell Algorithm This method, sometimes called the Southwell (1980) reconstructor is also a zonal method When the linear integration is made from one point to another following two different paths, the two results may by slightly different due to several factors like measurement errors in the spot positions, local wavefront deviations from sphericity, and numerical errors.

Hn ( 1 , . . . , n ) X( 1 ) . . . , X( n ) (A.3)

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The idea behind this method is to take into account the wavefront deformation for some vertical and horizontal adjacent spots in the calculation of the wavefront deformation for all spots Southwell proposed an iterative solution where for any point n; m the wavefront is calculated with Eqs (1010) and (1011) integrating from four neighboring points, one above, one below, one at the left, and one to the right of the point being considered as illustrated in Figure 109 Then, the nal value Wn,m is just the average of the four values For notational simplicity, we de ne Sx n 1;m as Sx m n 1; d TAx n 1; m TAx n; m 2r 10:12.

and hence, (3.121) and (3.122) Then, by (3.115), the variances of the elements sol and sol of the Fisher score vector are (3.123) and (3.124) For Design 1, the variances (3.123) and (3.124) are equal to 0.0020 and 7.34 x lo3 and, for Design 2, to 0.0039 and 1.45 x lo4, respectively. These results show that the variances with Design 2 are nearly twice as large as those with Design 1, as could have been expected. For either design, 500 sets of Poisson observations with expectations (3.120) have been simulated next. From each of these sets, the Fisher scores (3.45) have been computed for 81 and 82. Histograms of these Fisher scores are shown in Fig. 3.2. As predicted, they are wider as the number of observations increases while their clustering around the origin agrees with (3.18). rn In 4, we will return to this increase of the variance of the Fisher score with the number of observations.

FDA enforcement mechanisms are often utilized progressively. A good example is the enforcement action against Glaxo SmithKline ( GSK ), which began in July 2002, identifying numerous significant cGMP violations found during a February/April 2002 inspection. A Warning Letter requested that the violations be corrected and stated that failure to correct the violations may result in regulatory action, including seizure and/or injunction. Although a limited follow-up FDA inspection in October 2002, found that some specific corrections were acceptable, the subsequent FDA inspections in November/December 2003 and September/November 2004, revealed continuing significant cGMP violations. FDA concluded that the firm s data and corrective plans were not adequate to correct the cGMP violations. GSK also initiated recall of some, but not all, lots of the two products. On March 4, 2005, in response to ongoing concerns about manufacturing quality, FDA and the DOJ initiated seizures of two GSK pharmaceuticals. The Agency initiated these seizures actions based on concerns that GSK s violation of manufacturing standards may have resulted in the production of poor quality drug products that could potentially pose risks to consumers. On April 28, 2005, FDA announced that GSK had signed a Consent Decree with FDA to correct manufacturing deficiencies at its Cidra, Puerto Rico, facility. The Consent Decree was initiated based on FDA s continued concerns that GSK s violation of manufacturing standards may have resulted in the production of drug products that could potentially pose risks to consumers.