Significance levels for stability pooling test: A simulation study

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 3, 2003, Pages 355-374

  Chen, Wen Jen ^a   Tsong, Yi ^b  

^a Center for Drug Evaluation and Research   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Expiration date; False positive rate; Linear fixed effect model; Stability pooling test; Standard stability analysis

Indexed keywords

DRUG;

ALGORITHM; ANALYTIC METHOD; ARTICLE; DRUG QUALITY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHELF LIFE; SIMULATION; STATISTICAL ANALYSIS;

ALGORITHMS; COMPUTER SIMULATION; DRUG STABILITY; DRUG STORAGE; MODELS, STATISTICAL; TIME FACTORS;

EID: 0043166227     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120022760     Document Type: Article

References (14)

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