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References 1 U.S. Food and Drug Administration’s Good Laboratory Practice for Nonclinical Laboratory Studies, Title 21, Vol. 1, Part 58. 2 Bjornsson et al. The Conduct of in vitro Drug-Drug Interaction Studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) Perspective, p815- 831, 2003. 3Tucker, Geoffrey T, Houston, J. Brian and Huang, Shiew-Mei. Optimizing Drug Development: Strategies to Assess Drug Metabolism/Transporter Interaction Potential –Toward a Consensus. Br J Clin Pharmacol. 2001 Jul; 52(1): 107-117.
Bioanalytical method validation l Specific SOPs define how FDA guidelines are applied in bioanalytical methods validation. l All methods used in GLP-compliant studies must be validated. Methods are tested for accuracy, pre- cision, selectivity, sensitivity, reproducibility and stability. l Routine sample analyses are conducted using quality controls (QCs) to accept and reject runs for GLP studies, or upon request. l Non-GLP studies may follow methods that have not been validated. Typically, the same methods validated for GLP-compliant studies are used for non-GLP studies; however, in non-GLP studies, QCs are not necessarily used to accept or reject each batch.
DDW
Scott Hickman MBA, Sekisui XenoTech Director of Global Marketing, has managed the customer experience for innovative life science companies for more than 25 years.
Dr Brian Ogilvie, Sekisui XenoTech Vice-President of Scientific Consulting, is an author on numerous posters and publications and an invited speaker at many conferences.
Tim Patterson ASQ CQA, CQM, Sekisui XenoTech Quality Assurance Manager, has more than 20 years of experience working in GMP and GLP regulated environments.
Advanced Cell Diagnostics Agilent Technologies, Inc Biostrata Ltd
BioTek Instruments, Inc BMG Labtech GmbH
4 3
22 23 29
ADVERTISEMENT INDEX 44
Corning, Inc
Horizon Discovery Group plc Labcyte, Inc
Quanterix Corporation Select Biosciences Ltd
24,OBC 14
IFC IBC
SLAS
Taconic Biosciences, Inc Tecan Trading AG TTP Labtech Ltd XCell Biosciences
47 27 19 21 6
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