Abstract
The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Workshop was convened to provide a forum for discussion and consensus building about incurred sample assay reproducibility for both nonclinical and clinical studies. Information about current regulatory perspectives on incurred sample reanalysis (ISR) was presented, implications of ISR for both large and small molecules were discussed, and the steering committee put forth recommendations for performing ISR. These recommendations from the Workshop, along with the subsequent evolution of approaches leading to a robust ISR program, may be used by scientists performing bioanalytical assays for regulated studies to provide additional confirmation of assay reproducibility for incurred samples.
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References
Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Workshop/Conference Report—Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays. AAPS Journal. 2007;9(1):E30–42.
Fast D, Kavetskaia O, Macrae P, Steenwyk R. A Pfizer process for demonstrating assay reproducibility in GLP studies. Boston MA: Applied Pharmaceutical Analysis 2007.
Bansal S. Repeat bioanalysis selection and reporting. Arlington, VA: AAPS Workshop: Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays;2006.
Rocci ML Jr, Devanarayan V, Haughey DB, Jardieu P. Confirmatory reanalysis of incurred bioanalytical samples. AAPS Journal. 2007;9(3):E336–43.
Jemal M, Ouyang Z, Powell ML. A strategy for a post-method-validation use of incurred biological samples for establishing the acceptability of a liquid chromatography/tandem mass-spectrometric method for quantitation of drugs in biological samples. Rapid Commun Mass Spectrom. 2002;16:1538–47.
Brockman AH, Hatsis P, Paton M, Wu J-T. Impact of differential recovery in bioanalysis: the example of bortezomib in whole blood. Anal Chem. 2007;79:1599–603.
Larsson M, Han F. Determination of rifalazil in dog plasma by liquid–liquid extraction and LC-MS/MS: quality assessment by incurred sample analysis. J Pharm Biomed Anal. 2007;45:616–24.
Acknowledgements
The authors wish to thank the speakers and moderators who participated in the sessions: Jo Marie Smolec, Intertek ALTA Analytical Laboratory; Steven Lowes, Advion BioServices; Surendra Bansal, Hoffman-La Roche; Philip Timmerman, Johnson & Johnson; Binodh DeSilva, Amgen; Marie Rock, Midwest BioResearch LLC; Steven Keller, PDL BioPharma; Viswanath Devanarayan, Abbott Laboratories; Mario Rocci, Prevalere Life Sciences; Min Chang, Biogen Idec; John Smeraglia, Pfizer; Qin Ji, Covance; and Saleh Hussain, Anapharm. The AAPS Contract Research Organization Focus Group, the AAPS Ligand Binding Assays Bioanalytical Focus Group, and the Bioanalytical Focus Group provided support and assistance for the planning of the Workshop. The European Bioanalysis Forum assisted as a co-sponsor of the Workshop. The staff of the AAPS Meetings and Expositions Department, particularly Sharon Pichon, Elizabeth Marburger, and Karen Ellis ably handled the arrangements for the Workshop.*
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*The views expressed in this article are those of the authors and do not reflect official policy at the FDA. No official endorsement by the FDA is intended or should be inferred.
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Fast, D.M., Kelley, M., Viswanathan, C.T. 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. AAPS J 11, 238–241 (2009). https://doi.org/10.1208/s12248-009-9100-9
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DOI: https://doi.org/10.1208/s12248-009-9100-9