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Introduction: In this study we aimed to determine the maximal isometric muscle strength of a healthy, normal-weight, pediatric population between 6 and 15 years of age using hand-held dynamometry to establish strength reference values. The secondary objective was determining the relationship between strength and anthropometric parameters.Methods: Four hundred normal-weight Chilean children, split into 10 age groups, separated by 1-year intervals, were evaluated. Each age group included between 35 and 55 children.Results: The strength values increased with increasing age and weight, with a correlation of 0.83 for age and 0.82 for weight. The results were similar to those reported in previous studies regarding the relationships among strength, age, and anthropometric parameters, but the reported strength differed.Conclusions: These results provide normal strength parameters for healthy and normal-weight Chilean children between 6 and 15 years of age and highlight the relevance of ethnicity in defining reference values for muscle strength in a pediatric population. Muscle Nerve 55: 16-22, 2017. [ABSTRACT FROM AUTHOR]

Axitinib, a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, showed improved progression-free survival over sorafenib in patients previously treated for advanced renal cell carcinoma in the AXIS trial. Although a few studies had established the efficacy and safety of axitinib in Asian patients, additional evaluation was necessary to obtain regulatory approval in several Asian countries, especially in light of ethnic differences that are known to exist in genetic polymorphisms for metabolizing enzymes such as cytochrome P450 (CYP) 3A5, CYP2C19 and uridine diphosphate glucuronosyltransferase (UGT) 1A1, which are involved in axitinib metabolism. Axitinib plasma pharmacokinetics following single or multiple administration of oral axitinib in Asian (Japanese or Chinese) healthy subjects as well as Asian patients with advanced solid tumors was compared with that obtained in Caucasians. Upon review, the data demonstrated that axitinib can be characterized as not sensitive to ethnic factors based on its pharmacokinetic and pharmacodynamic properties. Axitinib exhibited similar pharmacokinetics in Asian and non-Asian subjects. A pooled population pharmacokinetic analysis indicated lack of a clinically meaningful effect of ethnicity on axitinib disposition. Therefore, dose adjustment for axitinib on the basis of ethnicity is not currently warranted. [ABSTRACT FROM AUTHOR]

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In similarly designed clinical trials conducted in different regions or a multiregional trial, we sometimes observe different mean responses between trials or regions due to differences in distributions of an ethnic factor. Uesaka et al. (2003) used adjusted means for covariate, the distribution adjusted mean, to deal with such a situation. This paper examines distributional properties of the distribution adjusted mean and shows its applicability to comparison of mean responses from clinical trials where the distribution of an ethnic factor is different between regions. A real example and simulation results are shown. The results of this paper enable us to evaluate the similarity of different responses in clinical trials from different ethnic populations. [ABSTRACT FROM AUTHOR]

Multiregional clinical trials including Japanese subjects are playing a key role in new drug development in Japan. In addition to the consideration of differences in intrinsic and extrinsic ethnic factors, deciding the sample size of Japanese subjects is an important issue when a multiregional clinical trial is intended to be used for Japanese submission. Accumulated experience suggests that there are several points to consider, such as the basic principles described in the guidance document, drug development strategy, trial phase, and disease background. The difficulty of interpreting the results of Japanese trials should also be considered. [ABSTRACT FROM PUBLISHER]

In 1998, the International Conference on Harmonization (ICH) published a guidance to facilitate the registration of medicines among ICH regions including the European Union, the United States, and Japan by recommending a framework for evaluating the impact of ethnic factors on a medicine's effect, such as its efficacy and safety at a particular dosage and dose regimen (ICH E5, 1998). The purpose of ICH E5 is not only to evaluate the ethnic factor influence on safety, efficacy, dosage, and dose regimen, but also more importantly to minimize duplication of clinical data and allow extrapolation of foreign clinical data to a new region. In this article, statistical methods for evaluation of bridging studies based on the concepts of consistency (Shih, 2001), reproducibility/generalizability (Shao and Chow, 2002), the weighted Z-tests for the design of bridging studies (Lan et al., 2005), and similarity between the new and original region based in terms of positive treatment effect (Hsiao et al., 2007) are studied. The relative merits and disadvantages of these methods are compared by several examples. [ABSTRACT FROM PUBLISHER]

ObjectiveIn anticipation of the revision of the 1985 Food and Agricultural Organization/World Health Organization/United Nations University (FAO/ WHO/UNU) Expert Consultation Report on ‘Energy and Protein Requirements’, recent scientific knowledge on the principles underlying the estimation of energy requirement is reviewed.DesignThis paper carries out a historical review of the scientific rationale adopted by previous FAO/WHO technical reports on energy requirement, discusses the concepts used in assessing basal metabolic rate (BMR), energy expenditure, physical activity level (PAL), and examines current controversial areas. Recommendations and areas of future research are presented.ConclusionsThe database of the BMR predictive equations developed by the 1985 FAO/WHO/UNU Expert Consultation Report on Energy and Protein Requirements needs updating and expansion, applying strict and transparent selection criteria. The existence of an ethnic/tropical factor capable of affecting BMR is not supported by the available evidence. The factorial approach for the calculation of energy requirement, as set out in the 1985 report, should be retained. The estimate should have a normative rather than a prescriptive nature, except for the allowance provided for extra physical activity for sedentary populations, and for the prevention of non-communicable chronic diseases. The estimate of energy requirement of children below the age of 10 years should be made on the basis of energy expenditure rather than energy intake. The evidence of the existence of an ethnic/tropical factor is conflicting and no plausible mechanism has as yet been put forward. [ABSTRACT FROM AUTHOR]