국립세종도서관 메인화면

• ·표제/책임표시사항 체외진단용 의료기기의 임상평가와 인허가 / 대표저자 : 오흥범
• ·판사항 2판
• ·발행사항 서울 : 고려의학, 2015
• ·형태사항 453 p. :천연색삽화, 도표 ;26 cm
• ·표준번호/부호 ISBN: 9788970437859  93510 : \45000 
• ·분류기호 한국십진분류법-> 510.74  듀이십진분류법-> 610.28  
• ·주제명 의료 기기[醫療機器]인허가[認許可]

Part I 기초통계학 

Chapter 1 통계학의 기본 개념·3 
1. 자료의 정리 및 요약·········4 
2. R 통계프로그램···············10 
3. 확률분포함수(probability distribution function) 13 
4. 표본 추출과 표본 통계량28 
5. 정규분포에서 추출된 표본 통계량의 분포·············32 
6. 순서통계량(order statistics) ································36 
7. 조건부 확률와 베이즈 정리··································39 
8. 예 제··········· 42 

Chapter 2 추정 및 가설검정··45 
1. 점 추정(point estimation) 46 
2. 구간추정(interval estimation) ·····························51 
3. 가설검정(hypothesis testing)의 이론··················57 
4. 모평균에 대한 가설검정··66 
5. 모비율에 대한 가설검정··72 
6. 비모수적 자료분석··········84 
7. 예 제············ 91 

Chapter 3 검체 수 산정과 검체선정····························97 
1. 우위성(superiority) 평가·101 
2. 비열등성(non-inferiority) 평가·························103 
3. 동등성(equivalence) 평가106 
4. 국내 고위험군 바이러스 검사키트의 성능평가····108 
5. 검체선정····· 110 
6. 예 제·········· 114 

Chapter 4 회귀분석과 상관분석·································119 
1. 단순선형회귀모형(simple linear regression model) 121 
2. 잔차분석과 이상치·········130 
3. 상관분석(correlation analysis) ··························135 
4. 선형로지스틱 회귀분석(linear logistic regression) ·141 
5. 예 제·········· 146 
Part II 의료기기 임상평가 

Chapter 5 성능평가 및 인허가 관련 기본 개념·········153 
1. Clinical Laboratory Standards Institute (CLSI) ···154 
2. CLSI 평가 프로토콜(evaluation protocol) ·········156 
3. 검사실에서의 성능평가 및 정도관리에 대한 158 
4. 정량검사의 예비평가······161 
5. 체외진단용 시약의 안정성(stability) 평가··········166 
6. 성능평가 및 의료기기 인허가 관련 용어의 개념정리171 

Chapter 6 정성검사의 평가··199 
1. 정성검사에 있어 바이어스(bias)와 비정밀도(imprecision) 평가 199 
2. 정성검사의 진단정확도(diagnostic accuracy) 비교·208 
3. 양성예측도 및 음성예측도 구하기·······················213 
4. ROC curve를 이용한 성능비교···························214 
5. 두 정성검사 IVDD 성능의 일치율 평가··············217 
6. 예 제·········· 219 

Chapter 7 정량검사의 정밀도 평가···························223 
1. 반복정밀도(repeatability, within-run precision)의 추정과 평가 226 
2. 검사실내 정밀도(within-laboratory precision) 추정과 평가··· 231 
3. 하루 한 번 수행(One Run per Day) IVDD의 평가·234 
4. 분산분석법의 기본 개념237 
5. 예 제·········· 246 

Chapter 8 정량검사의 총분석오차 추정·····················251 
1. 총분석오차(total analytical error) 추정의 개요252 
2. 총분석오차 추정 및 검정의 모수적 방법············253 
3. 총분석오차 추정 및 검정의 비모수적 방법·········261 
4. 총분석오차의 기술방법··263 

Chapter 9 정량검사의 직선성 평가···························267 
1. 직선성 평가를 위한 검체 준비····························269 
2. 직선성 평가를 위한 통계분석 절차의 개요·········270 
3. 직선성 평가에 있어 정밀도(precision)에 대한 고려·271 
4. CLSI 가이드라인에 따른 직선성 평가 사례········272 
5. CAP survey에서의 보정검정/직선성 평가 사례··277 

Chapter 10 검출한계 설정과 검정····························285 
1. 검출한계 설정을 위한 통계이론··························286 
2. 검출한계 설정···············289 
3. 검출한계의 검정(verification) ····························292 
4. 정량한계 설정 및 검정을 위한 절차···················295 
5. 정량검사 결과보고에 대한 CLSI 지침················295 
6. Real-time PCR의 검출한계 설정·······················296 
7. 예 제·········· 299 

Chapter 11 정량검사의 비교·303 
1. 검체 선정··· 304 
2. 이상치 검출 305 
3. 직선성 평가 311 
4. 잔차분석····· 313 
5. 의학적 결정 316 
6. 예 제·········· 318 

Chapter 12 비선형 보정모델321 
1. Four-parameter logistic model (4PL model) ··323 
2. Five-parameter logistic model (5PL model) ···328 
3. 정량적 면역측정법에서의 보정(calibration) 사례····330 
4. 예 제·········· 336 

Chapter 13 참고구간 설정과 검정····························337 
1. 참고개체(reference individual)의 선정··············339 
2. 채혈 및 검사 전에 고려해야 할 사항··················341 
3. 참고구간 설정을 위한 최소 검체 수···················341 
4. 이상치 처리 342 
5. 참고구간 설정을 위한 통계적 방법론·················345 
6. 참고구간의 차용(transference)과 검정(verification) ··············· 350 
7. 예 제·········· 352 

Part III 의료기기 인허가 

Chapter 14 우리나라의 체외진단용 의료기기 인허가361 
1. 개 요·········· 361 
2. 우리나라 의료기기 관리 조직도··························362 
3. 체외진단용 의료기기 정의 및 분류·····················364 
4. 인허가 절차 367 
5. 사후관리 및 대응 ·········379 
6. 향후의 변화와 발전·······382 

Chapter 15 미국의 체외진단용 의료기기 인허가·······387 
1. 개 요·········· 387 
2. 체외진단용 의료기기의 정의 및 분류·················389 
3. 인허가 절차 393 
4. 사후관리 및 대응··········409 
5. 향후의 변화와 발전········411 

Chapter 16 유럽의 체외진단용 의료기기 인허가·······413 
1. 개 요·········· 413 
2. 체외진단용 의료기기의 정의 및 분류··················414 
3. 인허가 절차 418 
4. 사후 관리 및 대응·········427 
5. 향후의 변화와 발전·······428 

Chapter 17 중국의 체외진단용 의료기기 인허가······429 
1. 개 요·········· 429 
2. 체외진단시약의 등급분류·430 
3. 인허가 절차 432 
4. 사후관리 및 대응··········439 
5. 향후의 변화와 발전·······440 

한글 찾아보기·· 441 
영문 찾아보기· 447