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It is useful to think of the conceive stage as part of an innovation process and draw on ideas from Lemaitre and Stenier s description of the innovation process (Lemaitre and Stenier, 1988), although the scope of our conceive stage is somewhat different The conceive stage involves identifying a deliverable to be produced and the bene ts expected from the deliverable It begins with a trigger event (Lyles, 1981), when a member of an initiating organization perceives an opportunity or need At this point the project deliverable may be only a vague idea, and some initial development may be associated with the concept capture step Clari cation of purpose involving the identi cation of relevant performance objectives and their relative importance is another key step in the conceive stage.
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n=0 1 2 A2 + n2 for n = 1 2 3 4 for n = 5 6 n 1 (1.148)
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If the only subjects enrolled in phase I and II clinical trials had genotypes (discovered by pharmacogenetic testing) that indicated that a new drug was likely to be safe and/or ef cacious in them, the size of the clinical trial could be reduced, lowering costs and making it more likely that fewer subjects would respond adversely or not at all (Roses, 2000a; Shi et al, 2001) The question is, how would researchers know which genotypes are more likely to make a new drug safe and ef cacious Predictions based on the importance of a drug-metabolizing enzyme may not be realized A minor enzyme in the metabolism of a drug (eg, CYP1A2) may play a major role in ADRs and another that is estimated to be in the major metabolic pathway of several drugs (eg.
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This step may be problematic to the extent that different views about the appropriate objectives are held by in uential stakeholders who try to negotiate mutually acceptable objectives Objectives at this stage are likely to be ill de ned or developed as aspirational constraints (eg, latest completion date, minimum levels of functionality, maximum cost, and so on) Before the concept can be developed further, in a concept elaboration step, suf cient political support for the idea must be obtained and resources allocated to allow the idea to be re ned and made more explicit Other individuals, organizations, or potential stakeholders may become involved Support at this stage may be passive, merely allowing conceptualization to proceed, rather than an expression of positive approval of the project The focus of this stage is early cycles through the six Ws s framework of Figure 11.
We can write the impedance looking toward the module through a cable of length d as Zin ( d). This can also be expressed as Zin ( ) = = V ( ) vin e+j + vout e j = I ( ) (vin e+j vout e j )/R0 1 + m e j 2 R0 , 1 m e j 2 (57) (58)
, CYP2D6) may not be involved in as many ADRs because of the lower frequency of the harmful polymorphisms (Phillips et al, 2001) or the presence of compensatory pathways (Kalow and Grant, 1995) If tests used to screen subjects for clinical trials do not have high positive predictive values, some people in whom the drug would prove to be ef cacious and safe will be eliminated from the trial Rather than screen before phase I and II trials, the pharmacogenetic pro les can be obtained afterwards Those who tolerated and responded to a drug can be compared with those with ADRs or therapeutic failure The ensuing phase III trials, which enroll many more patients than phase I and II trials, could recruit only those patients with a favorable pharmacogenetic pro le [T]rials could be smaller and faster, and less expensive (Roses, 2000b) This approach poses two problems.
Eventually, an evaluation of the project concept and objectives as de ned to date becomes necessary the concept evaluation step in Table 21 Evaluation here (and later) is not simply a go/no-go decision, but a go/no-go/maybe decision A go decision takes the process into the the next stage A no-go decision causes it to stop A maybe decision involves iteration through one or more previous steps The basic process threat in this stage is moving on to design before the project concept and objectives have crystallized, and before effective concept evaluation Underlying this threat is a failure to foresee concept killer threats that reveal themselves later in the process and concept maker opportunities that may be lost without trace.
2.6 SUMMARY We have discussed three types of error that affect statistical computing:
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