Scope of the Study

The first step in the procedure is to define the purpose, objectives, and scope of the study. The more precisely this is done, the more focused and relevant the committee discussions can be. The next step is to collect all relevant information on the process under consideration. This includes flow diagrams, process equipment specifications, nominal flows, etc. The procedure is highly dependent on the reflabiUty of this information. Efforts expended here are worthwhile. Many committees use the flow sheet as the central stmcture to organize thek discussions. 

The present work involves the study of methyl glycosides and O-isopropylidene ketals of various isomeric deoxy sugars by mass spectrometry. Several of the compounds selected for the present study have free hydroxyl groups, and interpretation of their mass spectra shows the scope of the study of these and related deoxy sugar derivatives by mass spectrometry without prior substitution of all hydroxyl groups. Some of the candidates (compounds 4, 7, 8 and 10) are structurally related to biologically-derived deoxy sugars. 

The determination of the significant issues helps to structure the results from the LCI or LCIA phases according to the goal and scope of the study. Figure 7.3 demonstrates the reasons for the results obtained in the LCIA phase by means of two selected impact categories GWP and HTP. 

The spatial and temporal scope of the study determines the quantity of samples that require processing and storage and can put great pressures on laboratory capacity, potentially increasing the risk of compromising sample integrity and affecting the study quality. 

A fault event representing a failure or error which is not examined further because information is not available or because further development is beyond the scope of the study. 

Appendix C contains a list of the NDAs within the scope of the study. The drug products included in the study represent some of the largest dmg products as measured by annual sales, including so-called blockbuster drugs such as Capoten, Cardizem CD, Cipro, Claritin, Lupron Depot, Neurontin, Paxil, Pepcid, Pravachol,... 

If any later-filed generic applicant filed its ANDA with the requisite certification after January 1, 1992, even if the first generic applicant for a particular drug product filed its application prior to January 1, 1992, the drug product was included within the scope of the study. 

There may be additional drug products that have obtained a second 30-month stay that are not included within this study because the first ANDA with a paragraph IV certification was filed after January 1, 2001. See Chapter 1 for the scope of the study. 

The objective and scope of the study are determined by reviewing the protocol and relevant SOPs. 

An LCA typically starts by defining the goal and scope of the study. The goal and scope definitions are important since they define the level of detail in the study. The exact question to be answered using the LCA method is... 

Completeness requires that this part of Pressac s book12 also be examined. However, only those who have read and worked through this book from start to finish know what they would be getting into. To refute every nonsensical and illogical sentence and, even more so, every technically or physically incorrect statement made in this book on the subject of the gas-tight doors and windows - and unfortunately there are a great many such statements - would take an entire book.97 Within the scope of the study at hand, it is impossible to provide a complete analysis of Pressac s section of 29 oversized text pages. For this reason we shall choose just one example ... 

If an interviewee expressed uncertainty as to the validity of his/ her response, the data were omitted from the research findings. Information provided by the interviewees that was outside the scope of the study was excluded, for example ... 

A concise report describing the history and scope of the studies in the area of conducting polymers can be found in Kanatzidis, M. G. Chem. Eng. News, 1990, 68, 49, 36. 

These special directions added to the original terms of reference broadened the scope of the study to include not just deep-ocean and littoral operations but also any credible part of naval operations at risk for terrorist attacks. Although this study was initiated after September 11, 2001, it should be noted that the committee did not expand its charter to consider the roles for the Navy in homeland defense, with the exception of the ties of its continental United States (CONUS) force protection mission requirements in relation to U.S. naval bases neighboring civilian communities. 

Scope of Study. The number of variables screened was 3-15> 20, 30, bo and the number of observations was 5-30, 50, 100, 200, bOO, 600. Altogether some 300 combinations of variables and observations were examined. The number of runs for each combination ranged from 120-2190. It should be noted that the study was originally designed for far fewer combinations of variables and observations and runs per combination. However, due to the unexpected availability, for a short period, of a computer which was being phased out, the scope of the study was greatly expanded. 

Interpretation is the last stage of an LGA study, where the results obtained are presented in a synthetic way, presenting the critical sources of impacts and the options to reduce them. Interpretation involves a review of all the stages in the LGA process, to check the consistency ofthe assumptions and the data quality, in relation to the goal and scope of the study. 

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