• The Korean Journal of Applied Statistics
• /
• v.15 no.2
• /
• pp.281-296
• /
• 2002

On the new medical system separating the prescription and dispensing of the drug, the qualification of pharmacist in substitution of prescribed medicine was restricted, except bioequivalence-certified drugs. Also, Korean Food and Drug Association(KFDA) revised the bioequivalence regulation on August, 2001 Among many changes from old guideline, impressive one is the statistical consideration. Specially, to estimate and analyze bioequivalence measures, AUC and $C_{max}$, the log-transformed model is recommended and the equivalence interval is modified from $\pm$20 rule to [In(0.8),In(1.25)] one. This meaningful act is very hope-for because it is statistically reasonable and is agreed with worldwide bioequivalence guideline, including USA, EU, Japan and Canada. In this paper, we introduce the new regulation of assessing bioequivalence, announced at August, 2001, mainly on statistical view points. Key points for the new regulation are discussed and the minimum sample size based on simulation studies are proposed.

• Transactions of the Korean Society of Mechanical Engineers A
• /
• v.38 no.3
• /
• pp.283-288
• /
• 2014

The use of robots is no longer limited to the field of industrial robots and is now expanding into the fields of service and medical robots. In this light, a trajectory generation method that can respond instantaneously to the external environment is strongly required. Toward this end, this study proposes a method that enables a robot to change its trajectory in real-time using a convolution operation. The proposed method generates a trajectory in real time and satisfies the physical limits of the robot system such as acceleration and velocity limit. Moreover, a new way to improve the previous method (11), which generates inefficient trajectories in some cases owing to the characteristics of the trapezoidal shape of trajectories, is proposed by introducing a triangle shape. The validity and effectiveness of the proposed method is shown through a numerical simulation and a comparison with the previous convolution method.

• Journal of Biomedical Engineering Research
• /
• v.28 no.3
• /
• pp.429-440
• /
• 2007

A coded excitation has been studied to improve the performance for ultrasound imaging in term of SNR, imaging frame rate, contrast to tissue ratio, and so forth. However, it requires a complicated arbitrary waveform transmitter for each active channel that is typically composed of a multi-bit Digital-to-Analog Converter (DAC) and a linear power amplifier (LPA). Not only does the LPA increase the cost and size of a transmitter block, but it consumes much power, increasing the system complexity further and causing a heating-up problem. This paper proposes an optimized 1.5bit fourth order sigma-delta modulation technique applicable to design an efficient arbitrary waveform generator with greatly reduced power dissipation and hardware. The proposed SDM can provide a required SQNR with a low over-sampling ratio of 4. To this end, the loop coefficients are optimized to minimize the quantization noise power in signal band while maintaining system stability. In addition, the decision level for the 1.5 bit quantizer is optimized for a given input waveform, which results in the SQNR improvement of more than 5dB. Computer simulation results show that the SQNR of a FM(frequency modulated) signal generated by using the proposed method is about 26dB, and the peak side-lobe level (PSL) of its compressed waveform on receive is -48dB.

• Journal of Biomedical Engineering Research
• /
• v.29 no.2
• /
• pp.99-106
• /
• 2008

To improve $B_1$ homogeneity in high field MRI, the RF power is applied to the transmit array coil elements sequentially in the time-multiplexed way. Since only a single coil element is activated in a time-multiplexing slot, the global standing wave formation in the human body is greatly suppressed. The time-multiplexing slot width is on the order of micro seconds, hence, high-order-harmonic slices can be placed far from the transmit coil and simultaneous multiple slice selection can be avoided. The $B_1$ homogeneities of a birdcage coil and an eight-channel transmit array coil have been compared through finite difference time domain simulations. The simulation results indicate that the proposed technique can reduce the peak-to-peak $B_1$ inhomogeneity down to one fourth of the transmission with a birdcage coil on the central plane of the human head model at 3 T. The mimicking experiments at 3 T, eight separate experiments with a single coil element activated and image reconstruction by combining the eight images, also show promising results. It is expected that the proposed technique has some advantages over other $B_1$ improving methods in real practice since simple RF switching circuitries are only necessary and electromagnetic coupling between the coil elements is out of concern in its realization.

• Journal of Biomedical Engineering Research
• /
• v.37 no.5
• /
• pp.168-177
• /
• 2016

In this paper we present an implantable pressure sensor to measure real-time blood pressure by monitoring mechanical movement of artery. Sensor is composed of inductors (L) and capacitors (C) which are formed by microfabrication and direct bonding on two biocompatible substrates (quartz). When electrical potential is applied to the sensor, the inductors and capacitors generates a LC resonance circuit and produce characteristic resonant frequencies. Real-time variation of the resonant frequency is monitored by an external measurement system using inductive coupling. Structural and electrical simulation was performed by Computer Aided Engineering (CAE) programs, ANSYS and HFSS, to optimize geometry of sensor. Ultrafast laser (femto-second) cutting and MEMS process were executed as sensor fabrication methods with consideration of brittleness of the substrate and small radial artery size. After whole fabrication processes, we got sensors of $3mm{\times}15mm{\times}0.5mm$. Resonant frequency of the sensor was around 90 MHz at atmosphere (760 mmHg), and the sensor has good linearity without any hysteresis. Longterm (5 years) stability of the sensor was verified by thermal acceleration testing with Arrhenius model. Moreover, in-vitro cytotoxicity test was done to show biocompatiblity of the sensor and validation of real-time blood pressure measurement was verified with animal test by implant of the sensor. By integration with development of external interrogation system, the proposed sensor system will be a promising method to measure real-time blood pressure.

• Journal of Biomedical Engineering Research
• /
• v.23 no.5
• /
• pp.333-340
• /
• 2002

Powerline interference in bioelectric recordings is a common source of noise. IEF(Incremental Estimation Filter) has been used to eliminate powerline interferences in biosignals, especially in ECG(Electrocadiogram) signals. The constant incremental factor in the IEF filter, which affects the performance of noise rejection, is usually determined empirically or experimentally based on the input signals. This paper presents the design of neural network based IEF filter for time-varying control of the incremental factor. The proposed IEF filter is evaluated by applying to artificial signals as well as ECG signals of MIT-BIH database. For the relative comparison of noise-rejection performance, it is compared with adaptive noise canceler and conventional IEF filter. Simulation results show that the neural network based IEF filter outperforms these adaptive filters with respect to convergence speed and noise rejection is specific frequencies.

• Journal of Biomedical Engineering Research
• /
• v.30 no.4
• /
• pp.333-340
• /
• 2009

MR compatible coaxial-slot antenna for microwave hyperthermia was developed while its structure and size of each part were determined by computer simulation using finite element method(FEM). Its local heating performance was evaluated using tissue-mimic phantom and swine muscles. 2% agarose gel mixed with 6mM/$\ell$ $MnCl_2$ as a biological tissue-mimic phantom was heated by the proposed antenna driven by a 2.45GHz microwave generator. The temperature changes of the phantom were monitored using multi-channel digital thermometer at the distance of 0mm, 5mm, 10mm and 20mm from the tip center of the antenna. Also muscle tissue of swine was heated for 2 and 5minutes with 50W and 30W of microwave generator powers, respectively, to evaluate the local heating performance of the antenna. MRI compatibility was also verified by acquiring MR images and MR temperature map. MR signals were acquired from the agarose gel phantom using $T2^*$ GRE sequence with 1.5T clinical MRI scanner(Signa Echospeed, GE, Milwaukee, WI, U.S.A.) at Pusan Paik Hospital and were transferred to PC in order to reconstruct MR images and temperature map using proton resonance frequency(PRF) method and laboratory-developed phase unwrapping algorithm. Authors found that it has no severe distortion due to the antenna inserted into the phantom. Finally, we can conclude that the suggested coaxial-slot antenna has an excellent local heating performance for both of tissue-mimic phantom and swine muscle, and it is compatible to 1.5T MRI scanner.

• Journal of Biomedical Engineering Research
• /
• v.29 no.4
• /
• pp.323-328
• /
• 2008

A patient with respiratory disorders such as a sleep apnea is increasing as the obese patient increase on the modern society. Positive Airway Pressure (PAP) devices are used in curing patient with respiratory disorders and turn out to be efficacious for patients of 75%. However, these devices are required for evaluating their performance to improve their performance by the mechanical breathing simulator. Recently, the mechanical breathing simulator was studied by the real time feedback control. However, the mechanical breathing simulator by an open loop control was specially required in order to analyze the effect of flow rate and pressure after operating the breathing auxiliary devices. Therefore the aims of this study were to make the mechanical breathing simulator by a piston motion and a valve function from the characteristic test of valve and motor, and to duplicate the flow rate and pressure profiles of some breathing patterns: normal and three disorder patterns. The mechanical simulator is composed cylinder, valve, ball screw and the motor. Also, the characteristic test of the motor and the valve were accomplished in order to define the relationship between the characteristics of simulator and the breathing profiles. Then, the flow rate and pressure profile of human breathing patterns were duplicated by the control of motor and valve. The result showed that the simulator reasonably duplicated the characteristics of human patterns: normal, obstructive sleep apnea (OSA), mild hypopnea with snore and mouth expiration patterns. However, we need to improve this simulator in detail and to validate this method for other patterns.

• Korean Journal of Adult Nursing
• /
• v.27 no.2
• /
• pp.146-155
• /
• 2015

Purpose: The aim of this descriptive study was to explore the relationship between non-technical skills (NTSs) and cardiopulmonary resuscitation (CPR) performance of nurses' teams in simulated cardiac arrest in the hospital. Methods: The sample was 28 teams of nurses in one university hospital located in Seoul. A high fidelity simulator was used to enact simulated cardiac arrest. The nurse teams were scored by raters using both the CPR performance checklist and the NTSs checklist. Specifically the CPR performance checklist included critical actions; time elapsed to initiation of critical actions, and quality of cardiac compression. The NTSs checklist was comprised of leadership, communication, mutual performance monitoring, maintenance of guideline, and task management. Data were collected directly from manikin and video recordings. Results: There was a significant difference between the medians of the NTSs and CPR performance (Mann Whitney U=43.5, p=.014). In five subcategories, communication (p=.026), mutual performance monitoring (p=.005), and maintenance of guideline (p=.003) differed significantly with CPR performance in medians. Leadership (p=.053) and task management (p=.080) were not significantly different with CPR performance. Conclusion: The findings indicate that NTSs of teams in addition to technical skills of individual rescuers affect the outcome of CPR. NTSs development and assessment should be considered an integral part of resuscitation training.

• The Journal of the Acoustical Society of Korea
• /
• v.9 no.4
• /
• pp.18-32
• /
• 1990

Deeping on purpose, SAW device may have to function while immersed in a liquid. Those who are familiar with SAW devices would anticipate difficulty since the propagating surface waves will tend to radiate energy into the liquid and hence suffer attenuation. Thus, to design an immerable SAW device, more attention and full information about the wave properites is required to overcome the attenuation and get the highest SAW generation eficiency. Though numerical simulation, the optimal geometry of underwater SAW devices, such as optimal piezoelectric crystal cut, SAW propagation direction and nondimensional wave number(ka) is determined to get the maximum SAW excitation efficiency, the minimum attenuation in propagation and pure mode propagation for all the modes of surface wave propagation. The design technique can be appliedto an arbitrary combination of a piezoelectric layer, a substrate and a liquid medium. In this paper, PZT and PVDF layers and a steel substrate are use for the solid medium. The technique can be easily employed for the design of underwater sensors and actuators for the applications, such as sonar marine antifouling, industrial and medical uses.