메뉴 건너뛰기




Volumn 19, Issue 12, 2006, Pages 28-36

A statistical perspective on the ICH Q2A and Q2B guidelines for validation of analytical methods

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL RESEARCH; ARTICLE; ASSAY; DATA ANALYSIS; PRACTICE GUIDELINE; QUANTITATIVE ANALYSIS; STATISTICAL ANALYSIS; VALIDATION PROCESS;

EID: 33846221100     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (61)

References (9)
  • 1
    • 33846184616 scopus 로고    scopus 로고
    • Analytical method validation for biopharmaceuticals: A practical guide. Guide to Validation
    • Mar;
    • Krause SO. Analytical method validation for biopharmaceuticals: a practical guide. Guide to Validation. Supp to BioPharm Int. 2005 Mar; 26-34.
    • (2005) Supp to BioPharm Int , pp. 26-34
    • Krause, S.O.1
  • 2
    • 26944435918 scopus 로고    scopus 로고
    • Method validation guidelines. Guide to Bioanalytical Advances
    • Sep;
    • Kanarek AD. Method validation guidelines. Guide to Bioanalytical Advances. Supp to BioPharm Int. 2005 Sep; 28-33.
    • (2005) Supp to BioPharm Int , pp. 28-33
    • Kanarek, A.D.1
  • 5
    • 0018127669 scopus 로고
    • Statistical estimation of the minimal detectable concentration (sensitivity) for radioligand assays
    • Rodbard D. Statistical estimation of the minimal detectable concentration (sensitivity) for radioligand assays. Analytic Biochem. 1978;90:1-12.
    • (1978) Analytic Biochem , vol.90 , pp. 1-12
    • Rodbard, D.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.