OTC Sunscreen Drug Products: Towards Greater Protection

It is important for the public to know that sunscreens are not a panacea for the adverse effects of solar radiation and that they are not a substitute for avoidance of the sun. Along with the many benefits attributed to sunscreen products, there is also the risk that these products create a false sense of security among consumers. Consumers have also been susceptible to being misled about the promoted uses and relative value of sunscreen products. Finally, consumers have not always been well-informed about how and when such products should be applied. In regulating sunscreen products, the Food & Drug Association (FDA) has taken up many of these concerns as it seeks to ensure that such products are safe and effective and not misbranded. Relief and guidance from the FDA have come in the form of the Tentative Final Monograph (“TFMâ€) for Over-the-Counter (“OTCâ€) Sunscreen Drug Products, a comprehensive regulation of OTC sunscreen drug products, which, in its final form, will be codified in 21 C.F.R. §352. This paper first seeks, in background, to discuss the role of the TFM system in regulating sunscreen products. It will then both examine two prominent controversies, namely the problem of UVA protection and the proposed cap on SPF values, and then assess the related deficiencies of the current labeling scheme under the TFM for OTC Sunscreen Drug Products. Finally, the paper will discuss the barriers to more comprehensive protection in sunscreen products

Financing the embedded value of life insurance portfolios

In May 2004 the CFO Forum harmonized the various efforts of reporting the embedded valueof life insurance companies by issuing the European Embedded Value (EEV) Principles.In this working paper a methodology is proposed to derive a maximum lending amountfrom EEV figures without much additional data requirements from the originating insurer. The approach chosen is similar to that of other financing areas, e.g. real estate finance, where first a prudent best estimate valuation is done and later risk deductions are performed in the form of applying loan to value ratios, e.g. 60-80 % of the prudent amount. Here, this prudent value is called bankable embedded value and the loan to value analysis presented leads to the maximum lending amount. The deductions proposed to arrive at a maximum lending amount are based on parameter adjustments and risk allowances for unexpected risks. There is an analogy with insurers for determining their own capital needs. The methodology proposed is based on the stress test approach which increasingly gains popularity with insurance supervisors in Europe. --European embedded value,embedded value,life insurance policies,maximum lending amount,required capital,risk analysis,risk discount rate,value reporting and analysis,value sensitivity analysis

Financing the embedded value of life insurance portfolios

In May 2004 the CFO Forum harmonized the various efforts of reporting the embedded valueof life insurance companies by issuing the European Embedded Value (EEV) Principles.In this working paper a methodology is proposed to derive a maximum lending amountfrom EEV figures without much additional data requirements from the originating insurer. The approach chosen is similar to that of other financing areas, e.g. real estate finance, where first a prudent best estimate valuation is done and later risk deductions are performed in the form of applying loan to value ratios, e.g. 60-80 % of the prudent amount. Here, this prudent value is called bankable embedded value and the loan to value analysis presented leads to the maximum lending amount. The deductions proposed to arrive at a maximum lending amount are based on parameter adjustments and risk allowances for unexpected risks. There is an analogy with insurers for determining their own capital needs. The methodology proposed is based on the stress test approach which increasingly gains popularity with insurance supervisors in Europe

An Exploratory Study into the Use of Psychology Participant Panels in Psychology Departments in the United Kingdom

Psychology Participant Pools (PPP) are known to be used within psychology departments in the United Kingdom as a way to promote understanding of psychological research and as a means to aid students and researchers to collect data. However, there is currently no information regarding the different practices undertaken in each department. This article represents a first exploration in this endeavour by asking representatives from these departments to complete a survey. General findings revealed that the number of studies conducted were either under 20 or over 40, Level 4 students had to obtain slightly more credits than Level 5 students, a range of activities were observed for those participants who did not obtain all their credits, and the PPP was more often than not tied to a research methods module. Despite receiving responses from around only a third of departments, the results revealed a wide range of behaviours across the departments. We feel that these are useful for departments who wish to establish, or update, their own PPP, but also recognise that a larger study is required to more accurately capture the use of PPPs in the United Kingdom

Postcategorical auditory distraction in short-term memory: Insights from increased task load and task type

Task-irrelevant speech impairs short-term serial recall appreciably. On the interference-by-process account, the processing of physical (i.e., pre-categorical) changes in speech yields order cues that conflict with the serial-ordering process deployed to perform the serial recall task. In this view, the post-categorical properties (e.g., phonology, meaning) of speech play no role. The present study reassessed the implications of recent demonstrations of auditory post-categorical distraction in serial recall that have been taken as support for an alternative, attentional-diversion, account of the irrelevant speech effect. Focusing on the disruptive effect of emotionally valent compared to neutral words on serial recall, we show that the distracter-valence effect is eliminated under conditions—high task-encoding load—thought to shield against attentional diversion whereas the general effect of speech (neutral words compared to quiet) remains unaffected (Experiment 1). Furthermore, the distracter-valence effect generalizes to a task that does not require the processing of serial order—the missing-item task—while the effect of speech per se is attenuated in this task (Experiment 2). We conclude that post-categorical auditory distraction phenomena in serial short-term memory are incidental: they are observable in such a setting but, unlike the acoustically driven irrelevant speech effect, are not integral to it. As such, the findings support a duplex-mechanism account over a unitary view of auditory distraction

Knockout studies reveal an important role of <i>plasmodium</i> lipoic acid protein ligase a1 for asexual blood stage parasite survival

Lipoic acid (LA) is a dithiol-containing cofactor that is essential for the function of a-keto acid dehydrogenase complexes. LA acts as a reversible acyl group acceptor and 'swinging arm' during acyl-coenzyme A formation. The cofactor is post-translationally attached to the acyl-transferase subunits of the multienzyme complexes through the action of octanoyl (lipoyl): &lt;i&gt;N&lt;/i&gt;-octanoyl (lipoyl) transferase (LipB) or lipoic acid protein ligases (LplA). Remarkably, apicomplexan parasites possess LA biosynthesis as well as scavenging pathways and the two pathways are distributed between mitochondrion and a vestigial organelle, the apicoplast. The apicoplast-specific LipB is dispensable for parasite growth due to functional redundancy of the parasite's lipoic acid/octanoic acid ligases/transferases. In this study, we show that &lt;i&gt;LplA1&lt;/i&gt; plays a pivotal role during the development of the erythrocytic stages of the malaria parasite. Gene disruptions in the human malaria parasite &lt;i&gt;P.falciparum&lt;/i&gt; consistently were unsuccessful while in the rodent malaria model parasite &lt;i&gt;P. berghei&lt;/i&gt; the &lt;i&gt;LplA1&lt;/i&gt; gene locus was targeted by knock-in and knockout constructs. However, the &lt;i&gt;LplA1&lt;/i&gt; &lt;sup&gt;(-)&lt;/sup&gt; mutant could not be cloned suggesting a critical role of LplA1 for asexual parasite growth &lt;i&gt;in vitro&lt;/i&gt; and &lt;i&gt;in vivo&lt;/i&gt;. These experimental genetics data suggest that lipoylation during expansion in red blood cells largely occurs through salvage from the host erythrocytes and subsequent ligation of LA to the target proteins of the malaria parasite

The shape of invasion perclation clusters in random and correlated media

The shape of two-dimensional invasion percolation clusters are studied numerically for both non-trapping (NTIP) and trapping (TIP) invasion percolation processes. Two different anisotropy quantifiers, the anisotropy parameter and the asphericity are used for probing the degree of anisotropy of clusters. We observe that in spite of the difference in scaling properties of NTIP and TIP, there is no difference in the values of anisotropy quantifiers of these processes. Furthermore, we find that in completely random media, the invasion percolation clusters are on average slightly less isotropic than standard percolation clusters. Introducing isotropic long-range correlations into the media reduces the isotropy of the invasion percolation clusters. The effect is more pronounced for the case of persisting long-range correlations. The implication of boundary conditions on the shape of clusters is another subject of interest. Compared to the case of free boundary conditions, IP clusters of conventional rectangular geometry turn out to be more isotropic. Moreover, we see that in conventional rectangular geometry the NTIP clusters are more isotropic than TIP clusters

Restitution for mistaken payments: Whither mistakes of law?

The traditional rule at common law precluded restitution for payments made by mistake where the payer's mistake had been one of law. That rule was set aside in New Zealand in 1958. Other jurisdictions are likely soon to follow. This article considers the law of mistaken payments absent the traditional rule. Assuming restitution is available for mistakes of law, ought the payer's ability to recover nevertheless differ according to whether the mistake was one of law or one of fact? The thesis of this article is that an approach to mistaken payment cases that deals directly with the competing merits of the parties and the relevant policy concerns removes any need to distinguish between the two types of mistake. A distinction between mistakes of law and mistakes of fact should be irrelevant to the payer's ability to recover