Use of fit-for-purpose quality requirements in bioanalysis

[1]  Anthony J. DeStefano,et al.  Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations , 2009, The AAPS Journal.

[2]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007, The AAPS Journal.

[3]  H. Soares,et al.  Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report , 2005, Pharmaceutical Research.

[4]  Viswanath Devanarayan,et al.  Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.

[5]  A. Nedderman,et al.  Looking back through the MIST: a perspective of evolving strategies and key focus areas for metabolite safety analysis. , 2010, Bioanalysis.

[6]  P. Timmerman,et al.  Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum. , 2010, Bioanalysis.

[7]  Naidong Weng,et al.  Bioanalysis of drug in tissue: current status and challenges. , 2012, Bioanalysis.

[8]  Naidong Weng,et al.  Capsule review on bioanalytical method transfer: opportunities and challenges for chromatographic methods. , 2011, Bioanalysis.

[9]  Naidong Weng,et al.  Important considerations for quantitation of small-molecule biomarkers using LC-MS. , 2012, Bioanalysis.

[10]  J Cummings,et al.  Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs , 2010, British Journal of Cancer.