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Volumn 16, Issue 7, 1998, Pages 1125-1141

Statistical approaches to determine analytical variability and specifications: Application of experimental design and variance component analysis

Author keywords

Analytical variability; Experimental design; Statistically derived specifications; Variance component analysis

Indexed keywords

ARTICLE; DRUG ANALYSIS; DRUG DEVELOPMENT; DRUG POTENCY; DRUG SCREENING; METHODOLOGY; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS; VARIANCE;

EID: 0032031482     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0731-7085(97)00266-5     Document Type: Article
Times cited : (5)

References (16)
  • 6
    • 0003228192 scopus 로고
    • Guideline on validation of analytical procedures: Definitions and terminology
    • [6] International Conference on Harmonization, Guideline on Validation of Analytical Procedures: Definitions and Terminology, Federal Register 60 (1995) 11260-11262.
    • (1995) Federal Register , vol.60 , pp. 11260-11262
  • 7
    • 0001682062 scopus 로고    scopus 로고
    • Draft guideline on the validation of analytical procedures: Methodology
    • [7] International Conference on Harmonization, Draft Guideline on the Validation of Analytical Procedures: Methodology, Federal Register 61 (1996) 9316-9319.
    • (1996) Federal Register , vol.61 , pp. 9316-9319
  • 8
    • 0000230040 scopus 로고
    • Stability testing of new drug substances and products; guideline
    • [8] International Conference on Harmonization, Stability Testing of New Drug Substances and Products; Guideline, Federal Register 59 (1994) 48754-48759.
    • (1994) Federal Register , vol.59 , pp. 48754-48759
  • 13
    • 0001646014 scopus 로고
    • [13] W. Paul, Pharm. Technol. 15 (3) (1991) 130-141.
    • (1991) Pharm. Technol. , vol.15 , Issue.3 , pp. 130-141
    • Paul, W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.