GCC Publications

8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation
- Conference Report from the 8th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on Incurred Sample Stability (ISS) by GCC
- White Paper from the 7th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on Biomarker Bioanalytical Validation by GCC
- White Paper from the 5th and 6th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on ISR in multi‑analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)
- White Paper from the 5th GCC Closed Forum at the EBF - Published in Bioanalysis Journal

Coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover
- Conference Report from the 4th GCC Closed Forum at AAPS - Published in Bioanalysis Journal

Recommendations on the Interpretation of the new EMA Guidline on BMV by GCC for Bioanalysis
- White Paper from the 4th GCC at the AAPS and 5th GCC at the EBF - Published in Bioanalysis Journal

The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum
- Meeting Report from the 3rd GCC Closed Forum at the Reid Bioanalytical Forum - Published in Bioanalysis Journal

Recommendations on: Internal Standard Criteria; Stability; ISR and Recent 483s by the Global CRO Council (GCC) for Bioanalysis
- White Paper from the 2nd GCC Closed Forum at the 5th WRIB - Published in Bioanalysis Journal

Formation of a Global CRO Council (GCC) for Bioanalysis
- Meeting Report from the 1st GCC Closed Forum - Published in Bioanalysis Journal