Exact calculation of power and sample size in bioequivalence studies using two one‐sided tests

The number of subjects in a pharmacokinetic two‐period two‐treatment crossover bioequivalence study is typically small, most often less than 60. The most common approach to testing for bioequivalence is the two one‐sided tests procedure. No explicit mathematical formula for the power function in the context of the two one‐sided tests procedure exists in the statistical literature, although the exact power based on Owen's special case of bivariate noncentral t‐distribution has been tabulated and graphed. Several approximations have previously been published for the probability of rejection in the two one‐sided tests procedure for crossover bioequivalence studies. These approximations and associated sample size formulas are reviewed in this article and compared for various parameter combinations with exact power formulas derived here, which are computed analytically as univariate integrals and which have been validated by Monte Carlo simulations. The exact formulas for power and sample size are shown to improve markedly in realistic parameter settings over the previous approximations. Copyright © 2014 John Wiley & Sons, Ltd.     

Letter to the editor by the authors of Exact Calculation of Power and Sample Size in Bioequivalence Studies Using Two One‐sided Tests,Pharmaceutical Statistics,DOI: 10.1002/pst.1666

This article reflects the views of the authors and should not be construed to be those of the US Food and Drug Administration. Copyright © 2015 John Wiley & Sons, Ltd.     

Maintaining and Strengthening a Shaky Regime with Mnemonic Work: Inventing a Chinese National Day from 1949 Through 1987 in Taiwan

This paper investigates the invention of a Chinese National Day from 1949 through 1987 in Taiwan to illuminate the significance of mnemonic work in nation‐building. The 1949 Retreat after the Chinese Civil War resulted in a serious legitimacy crisis for the government of the Republic of China; thus, (re)inventing the National Day became an important mission to maintain and even strengthen this shaky regime. While the role of the standardized commemorative narrative in influencing people's collective memory is granted, this article emphasizes the aspect of embodied memory in nation‐remembering. I point out that the official Chinese nationalism constructed its National Day as “inevitably” bustling, memorialized, accepted, heroic, familial‐ized, blessed, and pivotal‐ized to shape the impression of a sacred and memorable day. This paper—while essentially consistent with Billig's argument of banal nationalism—suggests that national identity is accumulated by many symbolically encoded elements found in daily life; it goes further to argue that banal nationalism needs the “hot” nationalism found in special occasions to encode, refresh, and redefine the symbolic meaning of entities. That is, the oscillations between sacred and profane are needed to guarantee that patriotic emotions can be continually created and maintained.     

Urbanicity Moderates Associations between Family Income and Adolescent Academic Achievement

Research has shown that family income's relations to early childhood achievement is stronger in large inner cities and weaker in less urbanized areas. Research has not yet considered whether links between family income and achievement in adolescence differ across the urban to rural landscape. Using nationally representative data from the Early Childhood Longitudinal Study, Kindergarten Class of 1998–1999 (N ≈ 9,350), this study examines differences in family income's links with eighth‐grade achievement across large urban, small urban, suburban, and rural communities. The point at which income‐achievement links plateau occurs later in the income distribution in less urbanized areas. The magnitude of the association between family income and reading and science skills also differs across the urban‐rural continuum, such that family income has stronger relations to reading and science achievement in urban cities and weaker links in suburban and rural communities.     

Social Relations Model Analyses of Perceived Self‐Control and Trust in Families

How do people know which family member is trustworthy? In this study, the authors tested the hypothesis that people use their perception of a family member's self‐control as an indicator of his or her trustworthiness. Eighty‐four Dutch families consisting of 2 parents and 2 children completed questionnaires assessing each family member's trust in and perceived self‐control of the other 3 family members. This full‐family design enabled the authors to examine their hypothesis in horizontal relationships, between family members of equal status (i.e., parent–parent and sibling–sibling relationships), and vertical relationships, in which partners have unequal status (i.e., parent–child and child–parent relationships). Consistent with the hypothesis, Social Relations Model analyses showed that being perceived as having higher self‐control is related to greater trustworthiness among adults and children in the large majority of horizontal and vertical relationships (10 out of 12). These findings highlight that perceived self‐control is an important factor by which to gauge trustworthiness in families.     

The Role of Religiousness and Gender in Sexuality Among Mexican Adolescents

This study examined the role of religiousness and gender in age at first intercourse, and sexual expectations and values in Mexico, a macrocontext where the majority is Mexican and Catholic (83%). Participants were Catholic and nonreligious adolescents (54% girls) attending middle (71%) or high school. Findings indicated that Catholic adolescents engaged in sexual intercourse at later ages than nonreligious adolescents. Both religious attendance and importance of religion and values in sexual decision making were associated with more conservative sexual values. Boys who were raised Catholic were more likely to endorse female virginity values and were less likely to expect to wait to have sex until married than nonreligious boys. These associations were not significant among girls. Catholic boys may be more likely to internalize sexual double standard beliefs regarding premarital sex than nonreligious boys. This study expands our understanding of the role of religiousness in Mexican adolescents’ sexuality.     

THE RELATIONSHIP BETWEEN DEBT LEVEL AND FISCAL SUSTAINABILITY IN ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT COUNTRIES

In this article we unify the traditional approaches to testing for fiscal sustainability considering the stock‐flow system that fiscal variables configure. Our approach encompasses previous ways of testing for sustainability. The results obtained for a group of 17 Organization for Economic Cooperation and Development (OECD) countries point to weak fiscal sustainability, as well as to the existence of cointegration between deficit and debt, confirming the relevance of the stock‐flow approach. Allowing for structural breaks and multicointegration turns out to be of critical importance to assess whether the fiscal authorities apply their policies looking for sustainability and whether, simultaneously, they try to stabilize real debt target levels. (JEL H62, E62, C22)     

ON THE INTERNAL REVENUE SERVICE'S SERVICE AND ENFORCEMENT

Built on the seminal work of Graetz et al. (1986), this study considers a model of tax compliance in which the Internal Revenue Service (IRS) services as well as audits taxpayers as in the real world. Taxpayers are uncertain about whether their incomes are eligible for deduction/exemption, and may seek advice from the taxpayer service provided by the IRS to mitigate the uncertainty. We show: (1) while the society's preferred quality of taxpayer service is likely to be sufficiently high, the IRS's preferred quality of taxpayer service is only at an intermediate level; and (2) the conflict between the society and the IRS tends to be intensified as the cost of tax audits becomes lower. Evidence in support of our results is addressed. We also extend our model to addressing the issue of corruption in tax administration and to considering a dynamic model. (JEL D82, H26, K42)