Specifications justification

Perhaps because of this complexity, few studies on determining kld/ktt, in cross termination in copolymerization have been reported and most of the available data come from model studies, it is also usually assumed, without specific justification, that penultimate unit effects are unimportant in determining which reactions occur and that values of k klt for the homotermination reactions are similar to those in the corresponding homopolymerizations. 

There are many circumstances when a single-dose intravenous (IV) study can provide useful information for example, if the intended treatment route is intraper-itoneal (i.p.), or if the product will be administered to an open wound or injected into a muscle or a tumor, it might accidentally enter a blood vessel, and the knowledge gained from an IV study would be of value as well as one by the clinical route. Hence, if the intended clinical route is not IV, the absence of an additional study with IV dosing would require specific justification. 

Note Of the coefficients used in rotor lateral analysis, those for damping in annular clearances have the highest uncertainty and are therefore usually the first to be adjusted. The stiffness coefficients of annular clearances typically have low uncertainty and, therefore, should be adjusted only on the basis of supporting data. Adjustments of bearing coefficients require specific justification because the typical values are based on reliable empirical data. 

List of all applicable reports supporting formulation and design development (e.g., safety reports for excipients, raw material specification justification report for excipients). 

List all applicable reports supporting the development of finished product specifications and release parameters (e.g., finished product specification justification report). 

Even if firms have no right to compensation, governments may wish to compensate adversely affected industry to enhance the credibility of their claims of investment certainty, and to continue to attract private-sector investment. However, without a specific justification, payments to industry may, prima facie, constitute State aid. A justification might be provided by analogy to the stranded cost regime formulated and applied by the Commission under the 1996 Electricity Directive, which allowed for such compensation in the electricity sector. Similar arguments might be applied to other sectors. 

Although it was only a model, the idea of kindling superficially appeared to provide a disease-specific justification for the use of anticonvulsants in manic depression. It also opened up the possibility of defining a sort of drug that would reduce emotional reactivity, in the same way that anticonvulsants are believed to reduce the brain s nervous excitability. In this sense kindling gave birth to the notion of a mood stabiliser. However as David Healy has pointed out, it was not until Abbott laboratories started to research and market sodium valproate for manic depression that the idea of a mood stabiliser really took root (Healy 2006). 

Specification justification Analytical development/method history Stability/statistical analysis COAs (Ref Stds, Batch release)... 

The frequency and period stated are considered to represent typical requirements. Depending on site specific circumstances, fewer or additional readings may be required (i.e. only such variations are subject to site specific justification... 

The process model is used to set a context for the safety case argument and to focus specific justification for each of the main areas of concern, as indicated by the GSN. For the relevant phase of the project, testing of the new trains in traffic hours, the only elements of tte overall process for train movements represented by the process model Figure 7-5, which are changed from the existing Victoria Line, are those associated with the introduction of the new train and the signalling system. The changes comprise ... 

The first target is interpreted to mean that for, say SOO years accumulated operation of a PLC, it is tolerable for a design error to result in one failure. The period of 500 years is somewhat arbitrary, but is chosen such that this type of failure could be claimed not to dominate system unreliability. It is therefore claimed that 5000 years accumulated experience should provide a sufficient basis to claim an tqrpropriale level of reliability. No specific justification for this is provided except that the period for which experience is required is some 10 times the target MTBF. This factor is judged to be appropriate to give some confidence in the claim (if the failures occurred at random intervals, such a period would lead to betto than 85% confidence) and to make some allowance for the lack of maturity of software reliability modelling. 

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