In this feature we assess the global bioanalytical landscape in light of the draft ICH M10 bioanalytical method validation guideline published in 2019. Explore the impact of the draft guidance document through a selection of exclusive Bioanalysis journal and Bioanalysis Zone content.
In this editorial from Bioanalysis, a collection of experts from CROs across the globe provide a CRO perspective on the potential impact of the ICH M10 guidance.
GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline supplement
Bioanalysis has published a supplement presenting the Global CRO Council for Bioanalysis’ (GCC) feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline from the 13th GCC Closed Forum (LA, USA, 5 April 2019).
This white paper depicts ISS issues and concerns, providing helpful recommendations on ISS in the context of bioanalytical method development and application.
This article outlines the recommendations proposed at the 5th/6th GCC Closed Forum on biomarker bioanalytical method validation.
Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
This Conference Report deals with a variety of topics discussed at the 6th GCC Closed Forum on current bioanalytical interests, EMA recommendations and co-administered drugs stability.
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
This white paper article outlines the recommendations made by the GCC on the bioanalytical method stability implications of co-administered/co-formulated drugs.
Recommendations on ISR in multi‑analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)
This conference report deals with a variety of topics discussed at The 5th Global CRO Council for Bioanalysis (GCC) meeting on regulated bioanalysis.
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
This white paper article outlines recommendations on various topics (including internal standard criteria, stability, ISR and recent 483s) made by the GCC.