Use of fit-for-purpose quality requirements in bioanalysis

Author:

Jian Wenying1,Edom Richard W2,Weng Naidong3

Affiliation:

1. Wenying Jian is a Principle Scientist in the Bioanalytical Group from the Department of Drug Safety Sciences at Janssen (a Johnson & Johnson company, NJ, USA). Her work involves various bioanalytical activities for quantitation of drugs, metabolites and biomarkers in support of drug development in preclinical and clinical stages, including method development, assay validation, project management and study monitoring. Her research experience and interest center on application of advanced LC–MS...

2. Richard W Edom is a Scientific Director in the Bioanalytical Group from the Department of Drug Safety Sciences at Janssen (a Johnson & Johnson company). He is currently leading an LC–MS group focused on the quantification of drugs and metabolites in biological samples. In addition to generation of exposure data used for preclinical and clinical development of candidate new drugs, the group also has considerable activity and experience in the determination of small-molecule biomarkers. Typically, the...

3. Naidong Weng is Scientific Director and Head of the Bioanalytical Group from the Department of Drug Safety Sciences at Janssen (a Johnson & Johnson company). He is a pioneer for using hydrophilic interaction LC–MS/MS to quantify polar analytes in biological fluids and has two review articles on this topic, one of which was one of the top 50 most cited articles from Journal of Chromatographic B, 2000–2005.

Publisher

Future Science Ltd

Reference17 articles.

1. EMEA . Guideline on Bioanalytical Method Validation. EMEA, London, UK (2011) .

2. US FDA . Guidance for Industry: Bioanalytical Validation. US FDA, MD, USA (2001) .

3. Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

4. Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

5. US FDA . Guidance for Industry: Bioanalytical Validation (Draft). US FDA, MD, USA (2013) .

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