Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
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The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.
KEY WORDSharmonization incurred sample reanalysis regulated bioanalysis repeat analysis
We would like to acknowledge the contributions of Bernard Jeanbaptiste (SGS Life Science Services) for his input early in our team discussions.
- 4.FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration (CDER and CVM), May 2001; Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.
- 6.European Medicines Agency E. Guideline on bioanalytical method validation, MEA/CHMP/EWP/192217/2009, Committee for Medicinal Products for Human Use (CHMP), 21 July 2011; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
- 7.ANVISA. Resolution RE No. 899, of May 29, 2003. Brazil, D.O.U. 02/jun/2003: Brazilian National Surveillance Agency (ANVISA); 2003; Available from: http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/2003/899_03re_e.pdf.
- 8.ANVISA. Resolution RE 1170, of April 19, 2006. Brazil: Brazilian National Surveillance Agency (ANVISA); 2006.Google Scholar
- 9.ANVISA. Resolution RDC No. 27, of May 27, 2012. Brazil, D.O.U. 22/may/2012: Brazilian National Surveillance Agency (ANVISA); 2012.Google Scholar
- 10.Guideline on Bioanalytical Method Validation in Pharmaceutical Development (25 July 2013, MHLW, Japan); Available from: http://www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf.
- 11.Fast DM, Kelley M, Viswanathan CT, O’Shaughnessy J, King SP, Chaudhary A, 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. 2009;11(2):238–41.PubMedCentralPubMedCrossRefGoogle Scholar
- 12.FDA. Guidance for industry: bioanalytical method validation. Draft Guidance. US Department of Health and Human Services, Food and Drug Administration, (CDER and CVM); September 2013, Revision 1; Available From: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf.