Procedural elements involved in maintaining bioanalytical date integrity for good laboratory practices studies and regulated clinical studies

AAPS Journal

Volumn 9, Issue 2, 2007, Pages E123-E127

  James, Christopher A ^a   Hill, Howard M ^b  

^a AMGEN INC   (United States)

^b HUNTINGDON LIFE SCIENCES   (United Kingdom)

Author keywords

Audit trails; Bioanalytical methods validation; GLP; Sample integrity

Indexed keywords

DRUG;

ARTICLE; BIOEQUIVALENCE; COMPUTER SECURITY; COMPUTER SYSTEM; CONTAMINATION; DATA ANALYSIS; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; INFORMATION PROCESSING; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEDICAL INFORMATION SYSTEM; QUALITY CONTROL; SAMPLING; STORAGE; VALIDATION PROCESS;

EID: 34248155672     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0902014     Document Type: Article

References (7)

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3. Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9:E30-E42. serial online.
4. Food and Drug Administration. FDA Compliance Program Guidance Manual. Chapter 48: Program 7348.001. Rockville, MD: FDA; 2000.
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7. Committee for Proprietary Medicinal Products. Note for Guidance on Investigation of Bioavailability and Bioequivalence. Canary Wharf, London: CPMP,EWP,QWP-1401/98. 2001.