Beyond the Scope of This Study

OTA did not examine the implications for the competitiveness of the U.S.-based pharmaceutical industry of Federal policies affecting pharmaceutical R D. The U.S.-based industry is a leader in the discovery and development of new drugs, particularly important new drugs with global markets. The U.S.-based industry has introduced roughly one out of every four new compounds introduced to the world market since 1961 (68,342) and is so far unchallenged as the leader 

Federal policies affecting R D obviously affect the U, S.-based industry, but their influence on the relative competitiveness of the U.S.-based industry is much more difficult to predict. Most of the U.S. Federal policies in place today that affect drug R D are neutral with respect to the drug s country of origin. Whether the United States should adopt policies that explicitly encourage U.S.-based R D or manufacturing is beyond the scope of this project.2 

Pharmaceutical R D includes many different scientific and clinical activities (see box 1-A). 

2For an examination of the competitiveness of U.S.-based dedicated biotechnology companies, see OTA s recent report on the subject 

Regulatory Review Investigational New Drug (IND) Application—An application filed with the U.S. FDA prior to human testing. The IND application is a compilation of all known information about the compound. It also includes a description of the clinical research plan for the product and the specific protocol for phase I study. Unless the FDA says no, the IND is automatically approved after 30 days and clinical tests can begin. 

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Overall Assessment of R D for Environmental Protection. It is recognized by the researchers that a total analysis of the societal cost versus societal benefits of R D for environmental protection research is well beyond the scope of this study. 

Based on these considerations and the purpose of this study, disposal is the only disposition discussed in developing recommendations on exemption of waste that contains small amounts of hazardous substances based on risk. Consideration of dispositions of exempt materials other than disposal as nonhazardous waste is beyond the scope of this study. However, the principles used in this Report to define exempt waste based on risk also could be used to define exempt material for any other purpose. 

We describe the potential ethanol yield from almond hulls and whey, but we do not consider these materials for use in the ethanol facility. The technology exists to process almond hulls and whey for ethanol, while retaining their value as animal feed, but that activity requires an additional capital investment that is beyond the scope of this study. 

Helium pycnometry can also be used to obtain an estimate of porosity providing that the porous sample is sealed to prevent gas penetration. There are experimental problems that need to be addressed to ensure that the seal is effective and that it doesn t significantly alter the volume or weight of the sample which are beyond the scope of this study. 

The choice between these two alternative residuumprocessing methods depends on many economic factors, and how such a choice would be made is beyond the scope of this study. However, these two processes are compared in Reference 2. Figure 4, a summary chart from Reference 2, indicates that coking is the preferred choice if it is desired to convert 60% or more of the crude (Arabian Heavy, in this case) to prime (clean) products. 

Treblinka II has gone down in Holocaust history as an extermination camp, whereas the camp Treblinka I, closely associated with a gravel pit, has hardly figured in subject literature at all. Since it is beyond the scope of this study to analyze all the accounts that have been advanced with respect to Treblinka II, and since it is only our intent to consider the necessary prerequisites and consequences of the mass extermination alleged by the witnesses, we shall confine the following to the most striking points. 

Also, to provide completeness to this study a H2 storage medium is needed. It is beyond the scope of this study to evaluate all possible H2 storage systems. The incorporation of a metal hydride system provides one legitimate model for the assessment of downstream H2 distribution systems. By incorporating a MH storage and delivery system in this, two significant issues requiring additional research have been identified in the review process ... 

The milling equipment evaluated in this limited study was selected on the basis of their ability to supply precise and reproducible samples of a specific size range. The evaluation of other types of available mills, having similar capabilities, was beyond the scope of this study. A brief description of the mills evaluated is included below. 

Eogenetic feldspar dissolution and kaolinization are potential sources for the early-burial quartz overgrowths. Determination of the source for quartz outgrowths and overgrowths is beyond the scope of this study. 

Although determination of timing and the mechanism of mixing was beyond the scope of this study, the following constraints can be applied ... 

From a thorough understanding of fouling mechanisms, a well designed cleaning scheme can be developed. This seems however beyond the scope of this study. The choice of hydrophilic membranes is essential. As discussed in Chapter 2, many NOM parameters remain unknown and will be unknown for a given water. It would be useful to more clearly define those NOM characteristics that correlate with rejection and fouling characteristics. It is also important that research be carried out close to surface water conditions rather than in model systems (provided excessive complexity does not preclude results interpretation). 

Although it is well beyond the scope of this study, it seems possible to think about the economy of race (its production and circulation as value) together with the historical development of a money economy conventionally understood. A diacritical reading of, for example, Leyshon and Thrift (1996) with Lott (1999) might prove fruitful. 

Thus, weld behavior was quite variable, depending on crack location and temperature. These differences arose from a number of metallurgical effects, including compositional variations between the BM and weld wire and thermal cycling of the HAZ. Such factors altered the microstructure and influenced the austenite phase stability. A complex residual stress system was present in the welds as a result of weld metal solidification shrinkage and local plastic deformation of the HAZ. However, a detailed accounting of these factors is beyond the scope of this study. 

Columnar cells with nuclei at varied distances from the luminal border were distinguished throughout fetal development, as in adults. Functional interpretation of these cells is beyond the scope of this study. However, columnar cells of different morphological types have been described previously in adults, and certain columnar cells (with short microvilli) have been suggested as potential receptors (Moran et al., 1991, 1995). Further investigation is clearly needed on the apical characteristics of VNO columnar cells. For example, the present investigation and some previous studies (Johnson et al., 1985 Sten-saas et al., 1991) have noted some cilia in the adult human VNO. The precise distribution of these ciliated cells is important, since the non-sensory, receptor-free epithelium of the VNO of other mammals (Briepohl et al., 1979) also possess cilia. 

A detailed comparison of the above two schemes is quite a complex exercise and goes beyond the scope of this study. The purpose of this paragraph is to provide a preliminary economic assessment of the use of membrane reactors to improve the IGCC process in terms of production of a fuel for electric generation and the capture of carbon dioxide. 

Quite obviously a detailed probabilistic cost/benefit analysis of control strategies on acid pollutants is beyond the scope of this study, even if sufficient data were available. However, we believe there is some merit in determining or referring to some very broad orders of magnitude of costs associated with the result of possible environmental damage from acid precipitation (and associated photo-oxidants), and then analysing these costs in relation to each other and the costs of control. 

Lipid extraction from various plant materials, especially oilseeds, using SC-CO2 has been studied extensively over the last couple of decades as recently reviewed by Eggers [1]. It is beyond the scope of this study to present a comprehensive review. However, the effect of moisture on lipid extraction and residual proteins will be emphasized. Oilseeds are usually dried to <12% moisture after harvest for storage stability. Oil content varies from 20-22% in soybeans to 40-45% in canola. 

When the whole available potential range is scanned (approximately from +2 to —3 V vs SCE in aprotic media), the first reduction, as well as oxidation step, is followed by one or two other processes at more negative (more positive) potentials representing stepwise reduction (oxidation) of intermediates and products. Since various follow-up reactions occur after the first electron transfer, the interpretation of such voltammograms is very complicated, if at all possible, and would deserve special investigation that is beyond the scope of this study. 

There are several approaches leading to the formulation of these non-linear relationships. Unfortunately it is not possible to summarize them here because the field is very rich in the variety of systems and behaviors. Consequently, such a summary hes beyond the scope of this study. An excellent and detailed review is given in Ref. (Beris Edwards, 1994). However, let us mention that many attempts have been made to bring together continuum mechanics theories and molecular models in order to formulate appropriate constitutive equations for... 

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