Quality schematic representation

The CTD is organised into five modules. A schematic representation of the stmcture and hierarchy is shown in Figure 6.1. Module 1 is designed to contain region-specific information such as application forms and other administrative provisions that may apply. As such, it is not harmonised and is not considered part of the CTD. The other four modules present the technical data in a harmonised format. Module 2 should contain critical overview assessments of the quality, non-dinical and clinical data, together with summaries of the non-clinical and clinical data. The objective of this section is to provide reviewers with an introduction to the submission, and to orient... 

Fig. 11 Schematic representation of cascade effects of climate change on reservoir water quality (expressed as anoxia extent)...

Figure 23.2 shows a schematic representation of a boiler feedwater treatment system. Raw water from a reservoir, river, lake, borehole or a seawater desalination plant is fed to the steam system. However, it needs to be treated before it can be used for steam generation. The treatment required depends both on the quality of the raw water and the requirements of the utility system. The principal problems with raw water are1,2 ... 

Figure 6 is a schematic representation of a DNA histogram. The ability of the flow cytometer to rapidly count several thousand nuclei contributes to the sensitivity of this technique for DNA analysis. However, problems due to sample quality, staining, and instrumental artifacts should be recognized and minimized to insure accurate interpretation of data (B2). 

Fig. 2 Schematic representation of the relationship between input into a river, condition (state), water use, and water quality...

Figure E7.10b shows the SDF and compares it to that of circular tube flow of a Newtonian fluid. The SDF is broad with about 75% of the flow rate experiencing a strain below the mean strain. A better insight into the meaning of the SDF is obtained by following simultaneously the reduction of the striation thickness and the flow rates contributed by the various locations between the plates (Fig. E7.10c). The distance between the plates is divided into 10 layers. We assume for the schematic representation of the SDF that the strain is uniform within each layer. Let us consider in each alternate layer two cubical minor particles separated by a certain distance, such that the initial striation thickness is Tq. By following the deformation of the particles with time, we note that although the shear rate is uniform, since the residence time is different, the total strain experienced by the particle is minimal at the moving plate and increases as we approach the stationary plate. But the quality of the product of such a mixer will not be completely determined by the range of strains or striations across the flow field the flow rate of the various layers also plays a role, as Fig. E7.10c indicates. A sample collected at the exit will consist, for example, of 17% of a poorly mixed layer B and only 1%...

Figure 22.5. Schematic representation of a pressure rise test for dispersion quality.

Fig. 19. Schematic representation of a muitistage optimization procedure based on a series of total quality factors Qi-...

Upon proper die fill, one must consider whether the material will form a tablet. The tableting characteristics of powders depend on the viscoelastic properties of the material. The process of compaction has been defined as the compression and consolidation of a two-phase system due to an applied load. The quality of the compact depends on the compression and consolidation of the powder mass, decompression of the compact, ejection from the die, and subsequent scrape-off from the lower punch. A schematic representation of the compression process is shown in Fig. 1. Because these viscoelastic properties are time dependent, both the magnitude and the rate of application (and release) of the compression force affect tablet quality. 

Figure 6 Schematic representation of the organisation of a toxicology study, where the Study Director may be assumed to have immediate control over most parts of the study since the histopathology part is conducted at a CRO, the sponsor Quality Assurance may also have some control over this part (Figures 6 and 7 adapted from Beernaert et al., 2000).

Figure 7 Schematic representation of a contracted study, where the sponsor conducts certain parts of the study in his own test facilities for the Quality Assurance of the Study Director, it may not be possible to perform its functions with regard to these parts.

Figure 9 Schematic representation of possibilities for the reciprocal performance of Quality Assurance functions in a company with two different test facilities.

Figure 2 Schematic diagram of a DGT sampler designed for water quality monitoring and schematic representation of the free concentration profile of ionic species in the sampler when in contact with an aqueous solution. DBL is the diffusive boundary layer. (Reprinted with permission from Zhang H and Davison W (1995) Performance characteristics of diffusion gradients in thin films of the in situ measurement of trace metals in aqueous solution. Anaiytical Chemistry 67 3391-3400 American Chemical Society.)...

Figure 9.10 Schematic representation of a quality control card.

Fig. 1 Schematic representation of co-assembly of two oppositely charged ionic-neutral diblock copolymers in water into complex coacervate core micelles, in short C3Ms, with a core comprising the oppositely charged monomers surrounded by a shell of neutral, water-soluble monomers. The two monomer types in the corona may mix left) or segregate radially (mid-left), laterally (mid-right) or both radially and laterally (right) depending on the chemical composition of the block copolymers and hence the miscibility and differential solvent quality of the neutral monomers. This may lead to the formation of onion-like micelles, also known as core-shell-corona structures (mid-left), Janus micelles (mid-right) or patchy micelles, also known as raspberry-like micelles (right). Figure from Ref. [188]...

The line drawings are of a high quality, the photographs clear and the schematic representations of various phenomena described in the text and of breeding procedures well laid out. This ably written reference book will be of use to botanists, geneticists and plant breeders alike, bringing together as it does so many aspects of pollination and reproduction in plants ... 

Figure 11.3 Schematic representation of PIV data quality as a function of pulse delay time...

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