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Volumn 16, Issue 1, 2006, Pages 1-14

An alternative approach to evaluation of poolability for stability studies

Author keywords

Bracketing Design; Equivalence; Matrixing Design; Poolability

Indexed keywords

ANALYSIS OF COVARIANCE; ARTICLE; DATA ANALYSIS; EVALUATION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REGRESSION ANALYSIS; SIMULATION;

EID: 30344439794     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400500406421     Document Type: Article
Times cited : (5)

References (10)
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    • Guidance for Industry: ICH Q1E. Rockville, Maryland: Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologies Evaluation and Research
    • Guidance for Industry: ICH Q1E. (2004). Stability Data Evaluation. Rockville, Maryland: Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologies Evaluation and Research.
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  • 6
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    • Pooling data from stability studies: Testing the equality of batch degradation slopes
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    • Ruberg, S.J.1    Stegemen, J.W.2
  • 8
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    • Shelf life determination based on equivalence assessment
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    • (2003) J. Biopharm. Stat. , vol.13 , Issue.3 , pp. 431-449
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.