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As a consequence of HSDPA activation there is an increase in downlink interference, which in turn causes a power rise in the ongoing dedicated connections (DCHs). Hence, the total power at the transmitting end is given by: PTotal PCCH PDCH DPDCH PHSDPA 7:11

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dV[R(8,8)] = dv[Q(B). G ) ] = iOd,,fi(B)

-1 3 -1 3

Type of Analytical Procedure Characteristics Accuracy Precision Repeatability Intermediate precision Speci cityb Detection limit Quantitation limit Linearity Range

FIGURE 10.2. Hartmann test perspective schematics showing the Hartmann screen over a mirror to be tested.

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FIGURE 4.16 Measured E-plane (x z plane) and H -plane (y z plane) radiation patterns for the antenna studied in Figure 4.14 with = 100 . (a) f 1 = 1584 MHz, (b) f 2 = 2051 MHz. (From Ref. 12, C 1999 IEE, reprinted with permission.)

fraction of the full factorial design is tested at intermediate points in time If the full long-term stability data required for the proposed shelf life will not be available for review before submission to the regulatory agency, the full factorial design should be tested at 12 months and at the last scheduled point in time prior to submission Therefore, the FDA regulations require testing full factorial design at 0, 12, and 36 months for a matrixing design In addition, data from at least three time points, including initial, should be available for each factor combination through the rst 12 months of the study For matrixing at accelerated storage conditions, testing should occur at a minimum of three time points, including initial and nal, for each factor combination.

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The matrixing design should be as balanced as possible so that each factor combination is tested to the same extent over the duration of the study A matrixing design is applicable when the supporting data indicate predictable product stability and small variability A statistical justi cation for using a matrixing design could be based on evaluating the proposed matrixing design with respect to its power to detect differences in the degradation rates among the factors or the level of accuracy on estimating the shelf life A matrixing design performed across factors other than time points generally has less precision in shelf-life estimation and yields a shorter shelf life than the corresponding full design due to the confounding and aliasing effects [10] Matrixing design may have insuf cient power to detect main factors or factor interaction effects.

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Thus an excessive reduction in the number of factor combinations may produce an unreliable estimation of the shelf life due to the missing factor combinations On the other hand, a matrixing design on time points would often have similar ability as the full design to detect differences in rates of change among factors and to establish a reliable shelf life This is because full testing of all factor combinations would still be performed at both the initial and the last time points For illustration purposes, matrixing design will be implemented over time points, factors, and in both time points and factors The reader should be wise when choosing a design for a particular stability study and should have in mind that supporting data and justi cations have to be provided..

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