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

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

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

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

BACKGROUND: Voglibose is an alpha-glucosidase inhibitor. The purpose of this study was to evaluate the pharmacodynamic characteristics of voglibose for determining the appropriate study design and parameters for a pharmacodynamic equivalence study of voglibose. METHODS: This study consisted of two studies. The single dose study had an open and single sequence design. Nineteen subjects received placebo and then one tablet of voglibose on two consecutive days with sucrose. The multiple dose study was performed with the similar design, except that it was a multiple dose of the single dose study. Nine subjects who showed an effective response in the single dose study received placebo three times and then voglibose 4 times on two consecutive days. Serial blood samples for pharmacodynamic parameters were taken until 180 mins after each administration. The baseline adjusted maximum serum glucose level (G(max)) and area under the serum glucose level-time profiles were determined and compared. RESULTS: In the single dose study, the difference in G(max) was -10.6 +/- 28.7 mg/dL. The area under the serum glucose concentration-time curve (AUGC(0-1h)) of placebo and voglibose were 7825.0 +/- 1145.3 mg.min/dL, 7907.5 +/- 917.2 mg.min/dL, respectively. In the multiple dose study, the difference in G(max) was 46.6 +/- 16.1 mg/dL. The AUGC(0-1h) of placebo and voglibose were 8138.6 +/- 721.9 mg.min/dL and 6499.7 +/- 447.2 mg.min/dL, respectively. The G(max) and AUGC(0-1h) of the multiple dose study was significantly different between placebo and voglibose in paired t-test. CONCLUSION: The differences in G(max) and AUGC(0-1h) are suitable for pharmacodynamic parameters to evaluate bioequivalence of voglibose.
alpha-Glucosidases ; Glucose ; Inositol ; Sucrose ; Therapeutic Equivalency

OBJECTIVE: If medical information is integrated for management purposes, the efficiency of the system may increase. In addition, diagnostic abilities of physicians may be improved through the increased speed and accuracy of information processing. Medical databases must ensure high performance in terms of speed and reliability. In addition, access to medical information must be restricted to persons with proper authorization to ensure the privacy of patients. METHODS: Thus, the security of medical database systems with multiversion data requires both the existing management system and security policies. RESULTS: This study simulates the performance of a dynamic multiversion data management system in terms of security levels and update operations. CONCLUSION: The results show that a dynamic multiversion data management system increases disk availability more than a double version system. In addition, if the number of security levels is small, throughput will be improved because the security overhead will be low. However, frequent update operations will decrease throughput whenever versions are created at each interval.
Automatic Data Processing ; Dietary Sucrose ; Humans ; Privacy

No abstract available.
Animals ; Embryonic Structures* ; Freezing* ; Mice* ; Sucrose*