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Review
. 2007 Oct 5;9(3):E336-43.
doi: 10.1208/aapsj0903040.

Confirmatory reanalysis of incurred bioanalytical samples

Mario L Rocci Jr  1 , Viswanath Devanarayan, David B Haughey, Paula Jardieu
Affiliations
Review

Confirmatory reanalysis of incurred bioanalytical samples

Mario L Rocci Jr et al. AAPS J. .

Abstract

Bioanalytical methods used to support the drug development process are validated to ensure that they function in the manner in which they are intended. "Incurred" or study samples can vary in their composition when compared with the standards and quality control samples used to validate the method and analyze these samples. During the 3rd American Association of Pharmaceutical Scientists(AAPS)/Food and Drug Administration(FDA) Bioanalytical Workshop, it was suggested that the reproducibility in the analysis of incurred samples be evaluated in addition to the usual prestudy validation activities performed. This manuscript provides recommendations concerning the number and types of samples that should be analyzed in such an evaluation, as well as the manner in which the resultant data should be analyzed. Suggestions as to follow-up activities and data reporting are also discussed. This approach is at best a beginning and is offered as a platform for future discussion, comments, and revision.

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References

    1. Shah DD, Midha KK, Dighe SV, et al. Analytical methods validation bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharm Sci. 1992;81:309–312. doi: 10.1002/jps.2600810324. - DOI
    1. Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 2007;9:E43–E47. doi: 10.1208/aapsj0901005. - DOI
    1. Viswanathan CT, Bansal S, Booth B, et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007;9:E30–E42. doi: 10.1208/aapsj0901004. - DOI - PubMed
    1. Findlay JWA, Smith WC, Lee JW, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249–1273. doi: 10.1016/S0731-7085(99)00244-7. - DOI - PubMed
    1. Guidance for the Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services FDA (CDER) and (CVM); 2001.

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