13^th GCC for Bioanalysis Closed Forum will be fully dedicated to providing feedbacks on ICH M10 BMV Draft Guideline.

Considering the importance of this ICH Guideline, which will replace the regional ones such as FDA, EMA, MHLW etc, the GCC will be going through the draft guidance line by line to make sure we provide feedbacks on each single point to ensure the CROs opinions are sent to the participating Regulatory Agencies for completing the final version of this document.

7 teams have been built to work on ICH Draft Guidance

Team 1:

Introduction, Objective, Background, Scope, Partial, Cross Validation, Incurred Sample Reanalysis (ISR)

Chromatography I - Key Validation Parameters: Selectivity, Specificity, Matrix Effect, Calibration Curve, Accuracy, Precision, Quality Control, Carry-over, Stability, Dilution Integrity, Reinjections, Extraction Recovery

Chromatography II - Study Sample Analysis, Acceptance Criteria for an Analytical Run, Calibration Range Reanalysis, Reinjection of Study Samples, Reintegration of Chromatograms

LBA I – Key Validation parameters: Selectivity, Specificity, Calibration Curve, Accuracy, Precision, Quality Controls, Carry-over, Stability, Dilution Linearity, Hook Effect, including Parallelism, Minimum Required Dilution

LBA II - Study Sample Analysis, Acceptance Criteria for an Analytical Run, Calibration Range, Reanalysis of Study Samples including Critical Reagents

Reference Standards, Dried Matrix Methods, New or Alternative Technologies, Commercial and Diagnostic Kits, Analytes that are also Endogenous Compounds

General Principles of Method Development/Validation, Documentation for Validation and Bioanalytical Reports