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This chapter focuses specifically on the activities and questions that are involved in the generation of data to support the registration and approval of a drug candidate. The data generated in early stage studies provide confidence for deciding whether to advance a drug into more complicated and expensive trials in specific patient populations. During middle stage development it is critical to begin to characterize the dose-response relationship for efficacy and safety endpoints in the selected population. Late stage confirmatory clinical trials often utilize a broader study population than was studied during early development. Besides the general scientific and medical literature, there are several important sources of information that can help with the strategy for clinical development programs and the design of specific trials and their questions. The FDA provides access to guidance documents that outline regulatory requirements related to the development of drugs and devices.
Different aspects of people's interactions with money are best conceptualized using the drug and tool theories. The key question is when these models of money are most likely to guide behavior. We suggest that the Drug Theory characterizes motivationally active uses of money and that the Tool Theory characterizes behavior in motivationally cool situations.
Tests of economic theory often focus on choice outcomes and find significant individual differences in these outcomes. This variability may mask universal psychological processes that lead to different choices because of differences across cultures in the information people have available when making decisions. On this view, decision making research within and across cultures must focus on the processes underlying choice.
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