Software general considerations

System managers must maintain a System Definition SOP including a high-level description of the software architecture, general considerations, responsibilities, and a hst of current user manuals. [FDA 483, 1999]... 

Commercial process simulators have added optimization capabilities the specific details of which are naturally proprietary, but the general features of these codes are described in this chapter. Very large scale optimization problems of considerable economic value can be treated as shown by the examples presented earlier, and in the future improvements in power, robustness, speed of execution, and user-friendly interfaces of computers and software can be expected to expand the scope of optimization of large scale problems. 

At the present time, two methods are in common use for the determination of time-resolved anisotropy parameters—the single-photon counting or pulse method 55-56 and the frequency-domain or phase fluorometric methods. 57 59) These are described elsewhere in this series. Recently, both of these techniques have undergone considerable development, and there are a number of commercially available instruments which include analysis software. The question of which technique would be better for the study of membranes is therefore difficult to answer. Certainly, however, the multifrequency phase instruments are now fully comparable with the time-domain instruments, a situation which was not the case only a few years ago. Time-resolved measurements are generally rather more difficult to perform and may take considerably longer than the steady-state anisotropy measurements, and this should be borne in mind when samples are unstable or if information of kinetics is required. It is therefore important to evaluate the need to take such measurements in studies of membranes. Steady-state instruments are of course much less expensive, and considerable information can be extracted, although polarization optics are not usually supplied as standard. 

Hardware considerations for automated performance testing systems generally include the computer, software, monitor, and input devices. These features can be provided on multiple testing platforms, including personal computers, handheld personal digital assistants, Internet-based systems, or on platforms that are specially designed to simulate occupational contexts. 

Many fluorescent dyes and proteins now available enable multiple detection channels and the ability to multiplex related assays. HCS assays typically use at least two channels one for a DNA stain and another for the fluorophore of interest. In general, the maximum number of channels utilized at one time ranges from two to five. Instrument hardware and driver software determine the number of channels and fluorophores to be acquired. Some factors to consider here include illumination source (arc lamp or laser), filter and mirror requirements, number of cameras or PMT detectors, camera sensitivity, and desired detection wavelength range. Other considerations for multiplexing include read time, resolution, and assay time (for live cell imaging). 

Calibration is necessary for in-situ spectrometry in TLC. Either the peak height or the peak area data are measured, and used for calculation. Although the nonlinear calibration curve with an external standard method is used, however, it shows only a small deviation from linearity at small concentrations [94.95 and fulfils the requirement of routine pharmaceutical analysis 96,97J. One problem may be the saturation function of the calibration curve. Several linearisation equations have been constructed, which serve to calculate the point of determination on the basis of the calibration line and these linearisation equations are used in the software of some scanners. A more general problem is the saturation function of the calibration curve. It is a characteristic of a wide variety of adsorption-type phenomena, such as the Langmuir and the Michaelis-Menten law for enzyme kinetics as detailed in the literature [98. Saturation is also evident for the hyperbolic shape of the Kubelka-Munk equation that has to be taken into consideration when a large load is applied and has to be determined. 

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