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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.)
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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. 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. 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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Complete or partial deletion of color/ avor Change in inks, imprints SUPAC-IR level 1 excipient ranges No other changes Change in technical grade and/or speci cations Higher than SUPAC-IR level 1 but less than level 2 excipient ranges No other changes Change in technical grade and/or speci cations Higher than SUPAC-IR level 1 No other changes MR (ER): Noti cation and updated batch record Stability Application/ compendial requirements plus multipoint dissolution pro les in three other media (e.g., water, 0.1 N HCl, and USP buffer media at pH 4.5 and 6.8) until 80% of drug released or an asymptote is reached Apply some statistical test (f2 test) for comparing dissolution pro les No biostudy IR: Noti cation and updated batch record Stability Dissolution requirements: case A, case B, or case C Apply some statistical test (f2 test) for comparing dissolution pro les No biostudy
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The Fisher score of independent and Poisson distributed observations w for the parameter 8 k follows directly from (3.43):
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Once you have a safe route, mark the waypoints and determine their coordinates. There s no standard symbol for a waypoint, as there are other navigation details, such as position. Many navigators, however, use a square with a cross in the middle. Measure the distance and direction of each leg and note these down on a plan . It s a good idea to use a printed pro forma for this, or on the route-planning page of your navigation logbook. You will end up with something like this.
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triangle tip, and the upper edge of the V-shaped slot is ds from the patch edge. A probe feed is placed at point C for the proposed dual-frequency operation, where point C is the null-voltage point along the centerline AB for the fundamental TM10 mode of the unslotted triangular microstrip antenna. The frequency ratio of the two operating frequencies is controlled by the dimensions of the V-shaped slot and the position of the slot relative to the edge of the triangular patch. The lower and higher operating frequencies occur, respectively, at a frequency below and above the fundamental resonant frequency f 10 of the unslotted triangular microstrip antenna. A number of prototypes have been constructed. Figure 4.48 shows the measured return loss for a design in which the V-shaped slot was chosen to be of dimensions ( 1 , 2 , w 1 , w 2 ) = (52.5, 36, 13, 20 mm) and placed away from the patch edge at a distance ds = 7 mm. When there is no slot present, the fundamental resonant frequency of the antenna parameters (L = 91 mm, h = 13.5 mm) studied here is about 1800 MHz. From the results obtained, it is seen that the two operating frequencies at 1524 and 2342 MHz are excited with good matching conditions, which gives a frequency ratio of about 1.537. The impedance bandwidths are found to be about 4.1% and 5.6% for the two operating bands centered at 1524 and 2342 MHz, respectively. Radiation patterns at the two operating frequencies were also measured, and the Eplane (x z plane) and H-plane (y z plane) patterns are plotted in Figure 4.49. Similar radiation characteristics for the two operating frequencies can be seen, both having the same polarization planes (y z plane) and showing relatively larger cross-polarization radiation in the H plane than in the E plane. The antenna gain in the broadside direction for the two operating frequencies is also about the same, and is measured to be about 7.0 dBi. By varying the dimensions of the V-shaped slot embedded in the triangular patch, different dual-frequency operations can be obtained. Table 4.12 lists the
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