• 제목/요약/키워드: validation guideline

검색결과 116건 처리시간 0.025초

항공기의 고도, 속도 및 깊은 실속의 회복을 위한 자동회복장치 설계 및 검증에 관한 연구 (A Study on the Design and Validation of Automatic Pitch Rocker System for Altitude, Speed and Deep Stall Recovery)

  • 김종섭
    • 제어로봇시스템학회논문지
    • /
    • 제15권2호
    • /
    • pp.240-248
    • /
    • 2009
  • Modem version of supersonic jet fighter aircraft must have been guaranteed appropriate controllability and stability in HAoA(High Angle of Attack). The HAoA flight control law have two parts, one is control law of departure prevention and the other is control law of departure recovery support. The control laws of departure prevention for advanced jet trainer consist of HAoA limiter, roll command limiter and rudder fader. The control laws of departure recovery support are consist of yaw-rate limiter and MPO(Manual Pitch Override) mode. The guideline of pitch rocking using MPO mode is simple, but operating skill of pitch rocking is very difficult by the pilot with inexperience of departure situation. Therefore, automatic deep stall recovery system is necessary. The system called the "Automatic Pitch Rocker System" or APRS, provided a pilot initiated automatic maneuver capable of an aircraft recoveries in situations of deep stall, speed and altitude. This paper addresses the design and validation for APRS to recovery of an deep stall without manual pitch rocking by the pilot. Also, this system is designed to recovery of speed, attitude and altitude after deep stall recovery using ATCS (Automatic Thrust Control System) and autopilot. Finally, this system is verified by real-time pilot evaluation using HQS (Handling Quality Simulator).

Analytical Method Validation of (-)Epicatechin gallate in Penthorum chinense Pursh Extract using HPLC

  • Kwon, Jin Gwan;Jung, Yeon Woo;Seo, Changon;Hong, Seong Su;Lee, Ji Eun;Shin, Hyun Tak;Jung, Su Young;Choi, Chun Whan;Kim, Jin Kyu
    • 한국자원식물학회:학술대회논문집
    • /
    • 한국자원식물학회 2019년도 춘계학술대회
    • /
    • pp.100-100
    • /
    • 2019
  • This study attempted to establish a High Performance Liquid Chromatography (HPLC) analysis method for the determination of (-)-epicatechin gallate as a part of the quality control for the development of functional cosmetic materials from Penthorum chinense Pursh extracts. HPLC was performed on a Unison US-C18 column ($4.6{\times}250mm$, $5{\mu}m$) with a gradient elution of 0.05% (v/v) trifluoroacetic acid (TFA) and methyl alcohol at a flow rate of 1.0 mL/min at $30^{\circ}C$. The analyte was detected at 280 nm. The HPLC method was performed in accordance with the International Conference on Harmonization (ICH) guideline (version 4, 2005) of analytical procedures with respect to specificity, precision, accuracy, and linearity. The limits of detection and quantitation were 0.11 and 0.33 mg/mL, respectively. Calibration curves showed good linearity (r2 > 0.9999), and the precision of analysis was satisfied (less than 0.6%). Recoveries of quantified compounds ranged from 99.51 to 101.92%. This result indicates that the established HPLC method is very useful for the determination of marker compound in P. chinense Pursh extracts.

  • PDF

Validation of Synovial Fluid Clinical Samples for Molecular Detection of Pathogens Causing Prosthetic Joint Infection Using GAPDH Housekeeping Gene as Internal Control

  • Jiyoung Lee;Eunyoung Baek;Hyesun Ahn;Youngnam Park;Geehyuk Kim;Sua Lim;Suchan Lee;Sunghyun Kim
    • 대한의생명과학회지
    • /
    • 제29권4호
    • /
    • pp.220-230
    • /
    • 2023
  • Identification of the pathogens causing infection is important in terms of patient's health management and infection control. Synovial fluids could be used as clinical samples to detect causative pathogens of prosthetic joint infections (PJIs) using molecular diagnostic assays, therefore, normalization and validation of clinical samples are necessary. Microbial culture is considered the gold standard for all infections, including PJIs. Recently, molecular diagnostic methods have been developed to overcome the limitation of microbial culture. Therefore, guideline for validating clinical samples to provide reliable results of molecular diagnostic assays for infectious diseases is required in clinical field. The present study aimed to develop an accurate validating method of synovial fluid clinical samples using GAPDH gene as an internal control to perform the quantitative PCR TaqMan probe assay to detect pathogens causing PJIs.

자하거 약침의 지표물질 선정 및 분석법 벨리데이션 (Identification of Standard Compound of Ja-ha-guh Pharmacopuncture and Validation of Analytic Methods)

  • 박상원;이재웅;이진호;하인혁;변장훈;정범환;정화진;이인희;김민정;김은지
    • 한방재활의학과학회지
    • /
    • 제26권1호
    • /
    • pp.33-40
    • /
    • 2016
  • Objectives Despite the increasing use of Ja-ha-guh (Hominis-placenta ) pharmacopuncture in rehabilitative medicine field, its standard compound has yet to be investigated. The purpose of this study is to provide standardization for future studies and increase satisfaction of patients by utilizing standard pharmacopuncture. Methods Alanine and leucine were selected as potential standard compounds. LC/MS was used to devise an analytic method. This analytic method was subject to validation. According to validation guideline of Korea Food and Drug Administration, the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy were measured. With this analysis, 3 lots of Ja-ha-guh pharmacopuncture were analyzed. Results Because the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy meet criteria of the guideline, the analytic method was validated. It was found that Ja-ha-guh pharmacopuncture contained $211.02{\pm}7.28ug/ml$ of alanine and $372.03{\pm}7.58ug/ml$ of leucine. Conclusions Both alanine and leucine appear to be suitable standard compounds. These results are likely to contribute to further standardization of Ja-ha-guh for medical use.

담배 흡입독성 평가를 위한 설치류 담배연기노출시스템의 유효화 (Validation of a Rodent Nose-only Exposure System for Inhalation Toxicity Evaluation of Cigarette Smoke)

  • 손형옥;이형석;신한재;박철훈;유지혜;장미;현학철
    • 한국연초학회지
    • /
    • 제36권1호
    • /
    • pp.20-25
    • /
    • 2014
  • As part of a balanced testing battery, subchronic inhalation studies on rats are performed to ensure that proposed cigarette modifications do not increase the toxicity of smoke and to demonstrate any instances where a modification may actually contribute to harm reduction. For subchronic inhalation studies with aerosols, the OECD suggests an exposure regimen of 6 hours/day (OECD Guideline 413, 1981), but alternative regimens have also been published: 1 hour/day and $2{\times}1$ hour/day. The aim of this study was to validate a rodent nose-only exposure system for the assessment of inhalation toxicity of cigarette smoke. In this study, cigarette smoke exposure system is consisted of cigarette smoke generator, smoke concentration adjusting system, and 20-port nose-only exposure system. Male SD rats were exposed for 35 days ($2{\times}1$ hour/day) to 3R4F Reference cigarette smoke and analysed major monitoring items of OECD Gudeline 413. WTPM, was measured in the test atmosphere, respiratory function (Buxco Biosystems) during exposure, postexposure urinary exposure biomarkers and alveolar neutrophiles in BAL fluid (Day 35) were evaluated. Validation demonstrated steady WTPM ($257{\pm}20ug/L$, $502{\pm}27ug/L$) and spatial uniformity (<10%). Nose port temperature ($22{\sim}26^{\circ}C$ and RH (45~75%) were acceptable over 35 days. Reductions in respiratory rate and minute volume and increase in the neutrophiles in BALF and the urinary exposure biomarkers were observed cigarette smoke dose dependently. This validation and 35-day inhalation study has shown that the rodent nose-only exposure system may be useful in the inhalation toxicity assessment of cigarette smoke.

Micro-mechanical modeling for compressive behavior of concrete material

  • Haleerattanawattana, P.;Senjuntichai, T.;Limsuwan, E.
    • Structural Engineering and Mechanics
    • /
    • 제18권5호
    • /
    • pp.691-707
    • /
    • 2004
  • This paper presents the micro-mechanical modeling for predicting concrete behavior under compressive loading. The model is able to represent the heterogeneities in the microstructure up to three phases, i.e., aggregate particles, matrix and interfaces. The smeared crack concept based on non-linear fracture mechanics is implemented in order to formulate the constitutive relation for each component. The splitting tensile strength is considered as a fracture criterion for cracking in micro-level. The finite element method is employed to simulate the model based on plane stress condition by using quadratic triangular elements. The validation of the model is verified by comparing with the experimental results. The influence of tensile strength from both aggregate and matrix phases on the concrete compressive strength is demonstrated. In addition, a guideline on selecting appropriate tensile strength for each phase to obtain specified concrete compressive strength is also presented.

마우스를 이용한 비만연구에서 활용되는 물리적 표현형 분석 기술 (Physical Phenotype Analysis in Obesity Study in vivo)

  • 김현경;고광웅
    • 식품과학과 산업
    • /
    • 제51권1호
    • /
    • pp.37-44
    • /
    • 2018
  • The prevalence of obesity is continually increasing in South Korea; about 1/3 of adults are diagnosed with obesity and 1/2 of adults are overweight in 2016. Abnormal body fat mass increased the risk factors of metabolic syndrome (including hypertension, type II diabetes, dyslipidemia), chronic kidney failure, osteoarthritis, and cardiovascular disease. Ministry of Food and Drug Safety (MFDS) in Korea established the validation and approval system for "functional food" based on related laws and regulations. According to the guideline of MFDS, the biomarkers for obesity study in vitro, in vivo, and clinical trial are well summarized. The analysis of physical phenotypes is necessary condition to study further molecular phenotypes and pathway analysis in vivo study. Thus, we will review currently available physical phenotype analysis; dual energy X-ray absorptiometry (DEXA) and Oxylet gas analysis will be examined in-depth.

Integrated Navigation and Sense & Avoid Systems for Micro Aerial Vehicles

  • Vorsmann, P.;Winkler, S.;Park, J.B.
    • 한국항해항만학회:학술대회논문집
    • /
    • 한국항해항만학회 2006년도 International Symposium on GPS/GNSS Vol.1
    • /
    • pp.145-150
    • /
    • 2006
  • The paper deals with integrated navigation and sense & avoid systems for small unmanned aerial vehicles (UAV). First an introduction to the current UAV activities of the institute is given. It is followed by an overview about the integrated navigation system developed for small UAVs. The system is based on a tightly-coupled GPS/INS architecture. But instead of using delta-ranges, time-differenced carrier phases are used to aid the INS. Finally, results from navigation filter validation in flight tests are presented. After that an overview about sense and avoid strategies for application in small unmanned aircraft is given. From this a guideline for developing such a system for the institute's UAVs is presented.

  • PDF

소유래 성분 원재료 사용 생물의약품과 의료기기 제조 공정에서 bovine adenovirus type 1 정량 검출을 위한 TaqMan probe real-time PCR (TaqMan probe real-time PCR for quantitative detection of bovine adenovirus type 1 during the manufacture of biologics and medical devices using bovine-derived raw materials)

  • 고운영;노나경;김인섭
    • 미생물학회지
    • /
    • 제51권3호
    • /
    • pp.199-208
    • /
    • 2015
  • 소의 혈액, 세포, 조직, 기관 등이 생물의약품, 조직공학제제, 세포치료제, 의료기기의 원재료로 널리 사용되고 있다. 소유래 성분 원재료에 다양한 바이러스가 오염된 사례가 있기 때문에 소유래 물질을 원재료로 사용한 제제의 바이러스 안전성 검증이 필수적으로 요구된다. Bovine adenovirus type 1(BAdV-1)은 소에게 가장 흔하게 감염되는 바이러스 중의 하나이다. 소유래 물질을 원재료로 하는 생물의약품, 조직공학제제, 세포치료제, 의료기기 등에서 BAdV-1 안전성을 확보하기 위해, 세포주, 원재료, 제조공정, 완제품에서 BAdV-1을 정량적으로 검출하고, 제조공정에서 BAdV-1 제거 검증을 위한 시험법으로 활용이 가능한 TaqMan probe real-time PCR 시험법을 확립하였다. 세포배양법에 의한 감염역가와 비교한 결과, real-time PCR 검출한계는 $7.44{\times}10^1\;TCID_{50}/ml$이었다. 확립 된 시험법의 신뢰성(reliability)을 보증하기 위해 시험법 검증을 실시한 결과, 특이성(specificity)과 재현성(reproducibility), 완건성(robustness)이 우수함을 확인하였다. 확립된 real-time PCR을 생물의약품 제조공정 검증에 적용할 수 있는지 확인한 결과, 인위적으로 BAdV-1을 오염시킨 Chinese Hamster Ovary(CHO) 세포주에서 BAdV-1를 정량적으로 검출할 수 있었다. 확립된 시험법을 항체의약품 생산용 CHO 마스터 세포주와 소유래 type 1 collagen에서 BAdV-1 검출 시험에 산업적으로 적용하였다. 위와 같은 결과에서 확립된 BAdV-1 real-time PCR 시험법은 감염역가 시험법과 같은 생물학적 시험법을 대신할 수 있는 신속하고, 특이성과 민감성이 우수한 시험법임을 확인하였다.

GC/MS를 이용한 식품 중 페놀 분석 (Determination of Phenol in Food using GC/MS)

  • 강영운;안지은;서정혁;박선희;윤혜정
    • 한국식품위생안전성학회지
    • /
    • 제29권4호
    • /
    • pp.312-315
    • /
    • 2014
  • 페놀은 보통 대기로 배출되며 반감기가 비교적 짧은 물질로서 환경에 농축되는 경우는 드물다. 하지만, 누출사고가 발생되어 수계나 토양에 오염될 경우 페놀에 오염된 농수산물의 안전성을 확보하기 위하여 페놀을 정확하게 검출할 수 있는 시험법을 확립하고자 하였다. 식품 중 페놀을 초음파추출기로 추출하고 GPC로 정제하여 GC/MS로 분석하는 시험법을 확립하였으며, 시험법의 유효성 확인을 위한 실험 결과들이 AOAC 가이드라인에서 제시하는 Criteria를 만족함으로써 시험법의 신뢰성을 확보할 수 있었다. 확립된 시험법은 식품 중 페놀의 오염조사 및 이행률 조사에 활용될 수 있다.