Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)

AbstractThe WHO guidelines on evaluating similar biotherapeutic products (SBPs) were adopted by the Expert Committee on Biological Standardization in 2009. The fundamental messages of the guidelines are that a) generic approach is not suitable for licensing SBPs, b) only products that have been subjected to a comparability exercise and show similarity to the reference biotherapeutic product (RBP) in terms of their quality, safety and efficacy are defined as SBPs, and c) the products that are not shown to be similar to the originator products as indicated in the guidelines should neither be described as "similar" nor called SBPs. In view of these, the products which have not been subjected to a head to head comparison with the RBP should be referred to as another term, e.g. ‘non-innovator’ therapeutic products.In order to review the current situation in each country, a survey was planned in line with the implementation workshop of the guidelines in August 2010. The results show that the diversity of regulatory framework for licensing SBPs and the ambiguous use of the terms, ‘similar’ or ‘generic’, present considerable challenges for the future use of SBPs

A Study on the Healthy Housing Quality of Multi-family Attached House According to Dwelling Unit Age

AbstractThe purpose of this study is to understand the healthy housing quality of four different multi-family attached house complexes that the constructions were finished at different years. In order to evaluate their healthy housing quality, the evaluation indicators of healthy housing, that have already existed, were used and the four complexes with different dwelling unit ages, located in Busan of Korea, were evaluated. For this, this study carry out residents’ evaluations of healthy housing quality through surveys on their satisfaction, and the study mainly identified characteristic according to dwelling unit age. According to the study, the health housing quality of multi-family attached house, of which the dwelling unit age is 10, begins to decrease in terms of managerial aspect. The healthy housing quality of social and managerial aspects is important for dwellers. The evaluation results can then be utilized to develop guidelines to manage and maintain healthy housing environments for apartments

Cooling of Hybrid Stars with Spin Down Compression

We study the cooling of hybrid stars coupling with spin-down. Due to the spin-down of hybrid stars, the interior density continuously increases, different neutrino reactions may be triggered(from the modified Urca process to the quark and nucleon direct Urca process) at different stages of evolution. We calculate the rate of neutrino emissivity of different reactions and simulate the cooling curves of the rotational hybrid stars. The results show the cooling curves of hybrid stars clearly depend on magnetic field if the direct urca reactions occur during the spin-down. Comparing the results of the rotational star model with the transitional static model, we find the cooling behavior of rotational model is more complicated, the temperature of star is higher, especially when direct urca reactions appear in process of rotation. And then we find that the predicted temperatures of some rotating hybrid stars are compatible with the pulsar's data which are contradiction with the results of transitional method.Comment: 8 pages, 5figures, accepted by RA

Improving Term Frequency Normalization for Multi-topical Documents, and Application to Language Modeling Approaches

Term frequency normalization is a serious issue since lengths of documents are various. Generally, documents become long due to two different reasons - verbosity and multi-topicality. First, verbosity means that the same topic is repeatedly mentioned by terms related to the topic, so that term frequency is more increased than the well-summarized one. Second, multi-topicality indicates that a document has a broad discussion of multi-topics, rather than single topic. Although these document characteristics should be differently handled, all previous methods of term frequency normalization have ignored these differences and have used a simplified length-driven approach which decreases the term frequency by only the length of a document, causing an unreasonable penalization. To attack this problem, we propose a novel TF normalization method which is a type of partially-axiomatic approach. We first formulate two formal constraints that the retrieval model should satisfy for documents having verbose and multi-topicality characteristic, respectively. Then, we modify language modeling approaches to better satisfy these two constraints, and derive novel smoothing methods. Experimental results show that the proposed method increases significantly the precision for keyword queries, and substantially improves MAP (Mean Average Precision) for verbose queries.Comment: 8 pages, conference paper, published in ECIR '0

The influence of dietary carbohydrate and fat on kidney calcification and the urinary excretion of N-acetyl-beta-glucosaminidase (EC 3.2.1.30).

1. Male Sprague-Dawley rats were fed on diets containing either sucrose or starch as the carbohydrate component. In one experiment, the diets also contained 200 g either butter or polyunsaturated margarine/kg; in a second experiment, the diets contained less fat in the form of 20 g maize oil/kg. 2. Over a period of 11 months assays were made in the urine of several ions and of the activity of the enzyme N-acetyl-β-glucosaminidase (β-2-acetamido-2-deoxy-β-D glucoside acetamidodeoxygluco-hydrolase; EC 3.2.1.30); at 13 months, examination was made of some of the abdominal viscera, especially of the kidneys. 3. In rats fed on the higher amount of fat, dietary sucrose produced a higher activity of the enzyme than did dietary starch, and a greater excretion of inorganic phosphate. 4. With both the higher and lower amounts of dietary fat, sucrose led to an increase in the weight of the liver and of the kidneys, and an increase in the concentration of calcium and of phosphate in kidney tissue. With the higher amount of fat, sucrose also produced an increase in the concentration of magnesium in the kidney. There was no difference in the concentration of any of the ions assayed in the plasma or, apart from inorganic phosphate, in the urine. 5. The kidneys of the sucrose-fed rats showed nephrocalcinosis, mostly in the cortico-medullary region, and basophilic deposits in the tubules. Attention is drawn to this unusual occurrence of nephrocalcinosis in male rats