Three-stage sequential statistical dissolution testing rules

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 3, 2004, Pages 757-779

  Tsong, Yi ^a,b   Shen, Meiyu ^a   Shah, Vinod P ^a  

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

^b HFD 705 ^*  (United States)

Author keywords

3 Stage test; Dissolution test; Group sequential test; Hypothesis of coverage probability; Operating characteristics; Sampling inspection; Tolerance interval

Indexed keywords

ARTICLE; DRUG CAPSULE; DRUG DOSAGE FORM; DRUG SOLUBILITY; JAPAN; MEDICAL LITERATURE; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; STATISTICS; TABLET; UNITED STATES;

ALGORITHMS; CHEMISTRY, PHARMACEUTICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; QUALITY CONTROL; SOLUBILITY; TABLETS; UNITED STATES;

EID: 4644303117     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200025689     Document Type: Article

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