The equivalence margin is the largest difference that is clinically acceptable between the test (or experimental) drug and the active control (or reference) drug. This paper discusses the scientific principles, along with the regulatory issues, that need to be addressed when determining the equivalence margin for the biosimilar product. The concept of assay sensitivity is introduced, and the ways to ensure assay sensitivity in the equivalence trial are emphasized. A hypothetical example is presented to show how an equivalence margin is determined. The regulatory agency should carefully assess if the equivalence margin of the biosimilar product was determined using a scientifically valid and clinically relevant approach, not subject to selection bias. This is important because the consumer risk of erroneously declaring equivalence when in fact it is not must be controlled conservatively low in the approval of any biosimilar products.
Dietary Sucrose ; Selection Bias

Transport of molecules across the intestinal epithelium takes place through 2 major routes, ie, trans-cellular and paracellular. Assessment of intestinal permeability is performed to assess the overall function of transport through the intestinal epithelial paracellular route. Urinary excretion of disaccharides and monosaccharides and ratio of their excretion is a basis for measurement of intestinal permeability. Lactulose and mannitol ratio is the most commonly used test for assessment of small intestinal permeability and the most reliable method for measurement of concentration of lactulose and mannitol in the urine is high performance liquid chromatography. After the measurement of concentration of probes in the urine; the results are expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in the urine. Testing of intestinal permeability is not required for routine patient care, however it is an important tool to understand the function of the paracellular transport in the research setting. Increase in intestinal permeability has been implicated in the pathogenesis of many autoimmune diseases including celiac disease, Crohn's disease, type I diabetes and food allergy.
Autoimmune Diseases ; Celiac Disease ; Chromatography, Liquid ; Crohn Disease ; Disaccharides ; Food Hypersensitivity ; Hypogonadism ; Intestinal Mucosa ; Intestine, Small ; Lactulose ; Mannitol ; Mitochondrial Diseases ; Monosaccharides ; Ophthalmoplegia ; Patient Care ; Permeability

Septoplasty is one of the most commonly performed operations in Otolaryngology. It is often considered an easy operation. Yet it is still accompanied by a relatively high rate of failure and complications. It is definitely not an operation in which one surgical technique can suffice for all circumstances. Rather it requires a variety of techniques in accordance to the various septal pathologies in order to achieve a favorable outcome. This study provides a comprehensive review of septoplasty including current concepts, historical background, classification, updated surgical techniques, and management of complications. In particular, the surgical techniques that ensure a successful correction and minimal complications are highlighted.
Dietary Sucrose ; Nasal Septum ; Otolaryngology

PURPOSE: The purpose of this study was to evaluate the effect of abutment material on screw-loosening before and after cyclic loading. Among the different materials of abutments, zirconia and metal abutment were used. MATERIAL AND METHODS:: Two types of implant systems: external butt joint (US II, Osstem Implant, Korea) and internal conical joint (GS II, Osstem Implant, Korea) were used. In each type, specimens were divided into two different kinds of abutments: zirconia and metal (n = 5). The implant was rigidly held in a special holding to device ensure fixation. Abutment was connected to 30 Ncm with digital torque gauge, and was retightened in 30 Ncm after 10 minutes. The initial removal torque values were measured. The same specimens were tightened in 30 Ncm again and held in the cycling loading simulator (Instron, USA) according to ISO/FPIS 1480. Cycling loading tests were performed at loads 10 to 250 N, for 1 million cycles, at 14 Hz, (by subjecting sinusoidal wave from 10 to 250 N at a frequency of 14 Hz for 1 million cycles,) and then postload removal torque values were evaluated. RESULTS: 1. In all samples, the removal values of abutment screw were lower than tightening torque values (30 Ncm), but the phenomenon of the screw loosening was not observed. 2. In both of the implant systems, initial and postload removal torque of zirconia abutment were significantly higher than those of metal abutment (P < .05). 3. In both of the implant systems, the difference in removal torque ratio between zirconia abutment and metal abutment was not significant (P > .05). 4. In metal abutments, the removal torque ratio of GS II system (internal conical joint system) was lower than that of US II system (external butt joint system) (P < .05). 5. In zirconia abutments, the difference in removal torque ratio between the two implant systems was not significant (P > .05). CONCLUSION: Zirconia abutment had a good screw joint stability in the condition of one million cycling loading.
Dietary Sucrose ; Joints ; Torque ; Zirconium

BACKGROUND: The accurate and rapid identification (ID) of nonfermentative gram-negative bacilli (NFB) is essential for diagnostic and therapeutic purposes and for epidemiologic studies of hospital infections. Commercial identification systems of NFB are easy to use but too expensive. The aim of the study was to develop a simple system for the identification of NFB species which are frequently isolated from clinical specimens. METHODS: Eighteen biochemical tests used in NFB microplate ID system were pyocyanin in Tech media; pyoverdin in Flo media; glucose fermentation, acid formation from glucose, maltose, lactose, sucrose, and mannitol in oxidation-fermentation media; Nitrate and nitrite reduction in nitrate media; fornithine decarboxylase, lysine decarboxylase, and arginine dihydrolase in Moeller decarboxylase media; acetamide, urease, citrate, 42degrees C growth, and oxidase test. For the establishment of NFB's biochemical data in microplate ID system, 175 consecutive isolates of NFB from clinical specimens isolated during the period of April 2000 were simultaneously tested by microplate method and API 32GN. RESULTS: Ninety-two percent of clinical isolates of NFB were identified to the species level by NFB microplate ID system. CONCLUSIONS: The NFB microplate ID system is simple to use, rapid and economical. Further modification are needed to improve the accuracy and identification rate of NFB isolates.
Arginine ; Citric Acid ; Cross Infection ; Fermentation ; Glucose ; Lactose ; Lysine ; Maltose ; Mannitol ; Oxidoreductases ; Pyocyanine ; Sucrose ; Urease

1. The saturated solution of starch, inulin and lactose could not inhibit the growth in media of monilia albicans. Trichophyton interdigitable and alternaria species. 2. In the cultivation findings of monilia albicans shows imperfect or dysfigured elementary pattern in saturated maltose, mannitol and ruffinose media, and was inhibited the growth by sucrose and dextrose lotion. 3. Saturated mannitol solution inhibit growth of trichophyton interdigitable strain and mannitol and dextrose inhibit the alternaria cultivation.
Alternaria ; Candida ; Fungi* ; Glucose ; Inulin ; Lactose ; Maltose ; Mannitol ; Saccharum* ; Starch ; Sucrose ; Trichophyton

Isolates of Ophiocordyceps heteropoda (Kobayasi) collected from Mt. Halla on Jeju-do, Korea were tested for mycelial growth on different agar media and in the presence of different carbon and nitrogen sources. Similarly, isolates were also incubated at different temperatures as well as under continuous light and dark conditions. Growth was better on Hamada agar, basal medium, and malt-yeast agar, but poor on Czapek-Dox agar. Different carbon sources such as dextrin, saccharose, starch, lactose, maltose, fructose, and dextrose resulted in better growth. Complex organic nitrogen sources such as yeast extract and peptone revealed the most effective growth. Mycelial growth was best at 25degrees C. The growth rate was faster in the dark than the light, but mycelial density was less compact in the dark.
Agar ; Carbon ; Cultural Characteristics ; Fructose ; Glucose ; Korea ; Lactose ; Light ; Maltose ; Nitrogen ; Peptones ; Starch ; Sucrose ; Yeasts

During the last four years, the pyrosequencing-based 454 platform has rapidly displaced the traditional Sanger sequencing method due to its high throughput and cost effectiveness. Meanwhile, the Sanger sequencing methodology still provides the longest reads, and paired-end sequencing that is based on that chemistry offers an opportunity to ensure accurate assembly results. In this report, we describe an optimized approach for hybrid de novo genome assembly using pyrosequencing data and varying amounts of Sanger-type reads. 454 platformderived contigs can be used as single non-breakable virtual reads or converted to simpler contigs that consist of editable, overlapping pseudoreads. These modified contigs maintain their integrity at the first jumpstarting assembly stage and are edited by fragmenting and rejoining. Pre-existing assembly software then can be applied for mixed assembly with 454-derived data and Sanger reads. An effective method for identifying genomic differences between reference and sample sequences in whole-genome resequencing procedures also is suggested.
Chimera ; Cost-Benefit Analysis ; Dietary Sucrose ; Genome

Necrotizing fasciitis is a rare, but life-threatening infection. Prompt diagnosis and early aggressive intervention is required for survival. However, there has been frequently occurred in delays of diagnosis and treatment due to its non-specific nature. Therefore, a high index of suspicion is needed to ensure timely intervention. We report a case of necrotizing fasciitis in a 7-day-old term healthy neonate.
Dietary Sucrose ; Fasciitis, Necrotizing ; Humans ; Infant, Newborn

In the UK, a person or organisation that creates risk is required to manage and control that risk so that it is reduced 'So Far As Is Reasonably Practicable' (SFAIRP). How the risk is managed is to be determined by those who create the risk. They have a duty to demonstrate that they have taken action to ensure all risk is reduced SFAIRP and must have documentary evidence, for example a risk assessment or safety case, to prove that they manage the risks their activities create. The UK Health and Safety Executive (HSE) does not tell organisations how to manage the risks they create but does inspect the quality of risk identification and management. This paper gives a brief overview of where responsibility for occupational health and safety lies in the UK, and how risk should be managed through risk assessment. The focus of the paper is three recent major UK incidents, all involving fatalities, and all of which were wholly avoidable if risks had been properly assessed and managed. The paper concludes with an analysis of the common failings of risk assessments and key actions for improvement.
Dietary Sucrose ; Humans ; Occupational Health ; Risk Assessment