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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..

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):

12 V

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.

Effect of Pesticides and Irradiation on the Ultimate Elongation of PE Films Percent Elongation after Treatment for 1 day and Xenotest Time (h)

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 448 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.

Vi n(f)

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 = 135 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 1537 The impedance bandwidths are found to be about 41% and 56% 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 449.

The equipment, system or facility fails to meet design standards The design fails to meet the performance specifications

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