SQA opinion paper on global harmonization of the bioanalytical method validation guidances

Bioanalysis

Volumn 2, Issue 12, 2010, Pages 1921-1925

  Tudan, Christopher ^a   Rogenthien, Stephen ^b   Jones, Anthony ^c  

^a Ricerca Biosciences LLC ^*  (Canada)

^b Ricerca Inc   (United States)

^c PharmaNet Development Group Inc   (United States)

Author keywords

bioanalytical method validation; FDA EMA regulations; global harmonization; method validation guidelines; Society of Quality Assurance (SQA)

Indexed keywords

ANALYTIC METHOD; BINDING ASSAY; BIOANALYSIS; IMMUNOASSAY; METABOLITE; PRACTICE GUIDELINE; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REVIEW; SAMPLE; STANDARDIZATION; VALIDATION PROCESS; BIOASSAY; ECONOMICS; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GENETIC PROCEDURES; INTERNATIONAL COOPERATION; METHODOLOGY; STANDARD; UNITED STATES;

BIOLOGICAL ASSAY; BIOSENSING TECHNIQUES; INTERNATIONAL COOPERATION; PRACTICE GUIDELINES AS TOPIC; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79952009940     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.162     Document Type: Review

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