Recommendations on biomarker assay validation (BAV) in tissues by GCC - This paper has just been published on Bioanalysis Journal.

16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status - This paper was published on Bioanalysis Journal.

Recommendations on qPCR/ddPCR Assay Validation by GCC - This White Paper was published on Bioanalysis Journal.

Recommendations on qPCR/ddPCR Assay Validation by GCC - This White Paper was published on Bioanalysis Journal.

Recommendations on ELISpot assay validation by the GCC - This White Paper was published on Bioanalysis Journal.

Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis - This White Paper was published on Bioanalysis Journal.

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline - This Paper was published on Bioanalysis Journal.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity - This Conference Report was published on Bioanalysis Journal.

WHITE PAPER: Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis - This White Paper was published on Bioanalysis Journal.

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation - This Conference Report was published on Bioanalysis Journal.

10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud - This Conference Report was published on Bioanalysis Journal

9th GCC: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks - This Conference Report was published on Bioanalysis Journal

WHITE PAPER: Recommendations on Incurred Sample Stability (ISS) by GCC - This White Paper was published on Bioanalysis Journal

WHITE PAPER: Recommendations on Biomarker Bioanalytical Validation by GCC - This White Paper was published on Bioanalysis Journal

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