RESUMEN
The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.
Asunto(s)
Biomarcadores , Citometría de Flujo , Citometría de Flujo/normas , Citometría de Flujo/métodos , Biomarcadores/análisis , Humanos , Secuenciación de Nucleótidos de Alto Rendimiento , Reacción en Cadena en Tiempo Real de la Polimerasa/métodosRESUMEN
Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.
Asunto(s)
Cromatografía Liquida/normas , Espectrometría de Masas en Tándem/normas , Tecnología Farmacéutica/normas , Benchmarking , Calibración , Consenso , Control de Calidad , Estándares de Referencia , Reproducibilidad de los Resultados , Tecnología Farmacéutica/métodosRESUMEN
The A8 Global Harmonization Team focused on the documentation needed to support both small and large molecule bioanalysis. Current regulatory requirements were compiled and compared. The scope of the team's discussions included the validation report, the bioanalytical report, study plans, raw data, and bioanalytical summaries for the common technical document (CTD). A common high-level table of contents for method validation and sample analysis reports is proposed. Suggestions have been made as to how the CTD can be standardized to improve usability and review. Additional comments have been made on reports of failure investigations, study plans, and raw data documentation. The recommendation is that no prescriptive guidelines are required in these areas but should be led by good scientific practices subject to particular circumstances.
