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Volumn 16, Issue 1, 2003, Pages 127-142

Application of the Multivariate T2 Control Chart and the Mason-Tracy-Young Decomposition Procedure to the Study of the Consistency of Impurity Profiles of Drug Substances

Author keywords

Chemical and pharmaceutical processes; Drug substances; Impurity profile; Multivariate control chart interpretation; Multivariate statistical process control

Indexed keywords

COMPUTER PROGRAM LISTINGS; DRUG PRODUCTS; STATISTICAL PROCESS CONTROL;

EID: 0141988661     PISSN: 08982112     EISSN: None     Source Type: Journal    
DOI: 10.1081/QEN-120020779     Document Type: Article
Times cited : (17)

References (12)
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    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Drug Information Branch, HFD-210; Center for Drug Evaluation and Research (CDER), Food and Drug Administration: Rockville, MD
    • Expert Working Group (Quality) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q3A Impurities in New Drug Substances, Drug Information Branch, HFD-210; Center for Drug Evaluation and Research (CDER), Food and Drug Administration: Rockville, MD, (1996); 1-9.
    • (1996) ICH Q3A Impurities in New Drug Substances , pp. 1-9
  • 4
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    • Multivariate quality control
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    • Hotelling, H. (1947). Multivariate quality control. In Techniques of Statistical Analysis; Eisenhart, C., Hastay, M., Wallis, W.A., Eds.; McGraw-Hill, Inc.: New York, 111-184.
    • (1947) Techniques of Statistical Analysis , pp. 111-184
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  • 5
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    • (1997) Proc. Am. Stat. Assoc. , pp. 143-145
    • Mason, R.L.1    Young, J.C.2
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  • 11
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    • Multivariate control charts for individual observations
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.