European medicines agency guideline on bioanalytical method validation: What more is there to say?

Bioanalysis

Volumn 4, Issue 8, 2012, Pages 865-868

  Smith, Graeme ^a  

^a HUNTINGDON LIFE SCIENCES   (United Kingdom)

Author keywords

bioanalytical method validation; European Medicines Agency; guidance for industry; guideline; US FDA

Indexed keywords

ACCURACY; BIOANALYTICAL METHOD VALIDATION; CLINICAL ASSESSMENT TOOL; CLINICAL STUDY; DRUG CONTAMINATION; DRUG QUALITY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; NOTE; PRACTICE GUIDELINE; TABLET MATRIX; VALIDATION PROCESS;

BIOTECHNOLOGY; CHEMISTRY TECHNIQUES, ANALYTICAL; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; LABORATORIES; REPRODUCIBILITY OF RESULTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84860307948     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.44     Document Type: Note

References (7)

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