Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability

European Journal of Pharmaceutical Sciences

Volumn 42, Issue 3, 2011, Pages 230-237

  Kamberi, Marika ^a   Garcia, Hector ^a   Feder, Debra P ^a   Rapoza, Richard J ^a  

^a ABBOTT VASCULAR   (United States)

Author keywords

Acceptance criteria; Assay variability; Drug eluting stent; Method validation; Random error; Sigma approach; Systematic error

Indexed keywords

ANALYTIC METHOD; ARTICLE; DRUG ELUTING STENT; HISTOGRAM; MONTE CARLO METHOD; PRIORITY JOURNAL; VALIDATION STUDY;

DRUG ADMINISTRATION ROUTES; MONTE CARLO METHOD; REPRODUCIBILITY OF RESULTS; STENTS;

EID: 79251593615     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2010.11.013     Document Type: Article

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