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pattern that would be the most appealing and emphasize the features of the object that were under test The most common type of DIC interferometer is used for qualitative observation of semitransparent biological samples; this system works in transmission and not on re ection Although neither as popular nor as commercially available as white light interference microscopes, a DIC interferometer can also deliver quantitative data about a surface pro le while working in re ective mode Some idea about the optical path difference between sheared wavefronts can be achieved by looking at created interference colors an comparing the to Michel-Levy and Lacroix who came up in 1889 with Interference Color Chart A more reliable technique, one that does not require color comparison and can be used with a black and white CCD camera, is based on phase shifting interferometry (see chapter on Phase Shifting Interferometry and Arnison et al.



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Then random module provides functions to provide random numbers distributed according to various formulae, such as the normal distribution. The following statistics functions are available: betavariable(a,b) The beta distribution. Probability density is xa-1(1 - x)b-1 / B( ,b), where B(a, b) = (a) (b) / (a+b). Both a and b must be greater than -1. cunifvariate(mean,arc) Circular uniform distribution. Both mean and arc must be an angle (in radians) from 0 to pi. expovariate(lambda) The exponential distribution. Probability density is e- x . gammavariate(a,lambda) The gamma distribution. Probability density is x( -1) e-x/b / ( ). must be larger than -1, and b must be larger than 0. gauss(mu,sigma) The Gaussian (normal) distribution with mean mu and standard deviation sigma. This is slightly faster than normalvariate. lognormvariate(mu,sigma) The log normal distribution. The natural logarithm of this distribution has mean mu and standard deviation sigma.





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Method Visibility Creating a Method Calling Methods Adding Parameters and Returning Values Accessing Object Properties from Methods Static Methods Using Hints to Check Method Arguments Making Your Classes Self-Contained with Encapsulation

, 2004) The phase shift between interfering beams can be obtained by shifting the Wollaston prism laterally or by rotating the polarizer However, the phase shift will be wavelength dependent, and the fringes will change contrast during the phase shift To avoid this changing contrast, achromatic phase shifting based on the geometric phase can be used (Hariharan, 1996) Once the optical path difference between sheared replica of the wavefront re ected from the object is obtained in two orthogonal directions, the original surface can be calculated The advantage of the DIC interferometer is that it is almost insensitive to vibrations since they are almost common path interferometers The major limitations of these interferometers, which include a short measurable depth and thickness of the object and index gradient, occur because of the limited depth of eld of the objective like in any other nonscanning interference microscope.

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The FDA s adoption of a risk-based orientation for regulation is the most important aspect of the twenty- rst-century cGMPs It is a common misconception that the agency s initiative describes a new set of practices for the industry In fact, while the FDA is committed to encouraging innovation in the industry, the twenty- rstcentury cGMPs initiative is entirely focused on changing the agency s regulatory framework so that quality and innovation are rewarded with reduced oversight Now that the agency has entered the implementation phase of the initiative, many of the previous regulatory disincentives have been eliminated In other words, pharmaceutical companies are currently free to voluntarily choose whether or not to pursue innovative changes in their development, operation, and quality assurance of manufacturing processes such as PAT.

Risk-Based Prioritization of cGMP Inspections The mechanism by which the FDA will encourage the industry to join in implementing the new methods is provided by the risk-based algorithm for prioritizing cGMP inspections Incidentally, risk-based site selection is the same mechanism which will allow the agency to optimally allocate its limited oversight resources to achieve the greatest public health impact Operational ef ciency is a major component of the FDA s plans for the future The key to the risk-based site selection program is the agency s riskranking model, which has been deployed as a pilot program since the beginning of its 2005 scal year The model is based on a hierarchical risk-ranking and risk- ltering method whereby a site risk potential (SRP) is estimated as a function of the weighted potentials for each of three top-level components of site risk product, facility, and process (Figure 8).

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