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EBF Workshop Presentation, Lisbon

Stuart’s presentation, entitled General Principles of Stability Testing: What Is A Single Source? formed part of the EBF’s Industry input into ICH M10: Experimental data as the cornerstone for a science driven bioanalytical guideline event.

The aim of the meeting was to share and discuss data and experience related to BMV and analysis and to propose industry’s best practice recommendations for consideration in different areas of the proposed new guideline. 

The two-day meeting consisted of an update on recent industry developments related to BMV, including general feedback from the sister meeting organised by the AAPS (in collaboration with JBF and EBF). 

Attendees also benefited from presentations, data driven workshops and the sharing of experimental data gathered from recent and targeted surveys on items such as ISR, LBA dilution testing and selectivity or interference testing. The meeting ended with suggestions for improvement and a proposed way forward. 

Stuart’s presentation focused on the necessity for stability tests to support study samples, design testing so that dependent variable, independent variables and experimental variables are defined and controlled, and suggested that a single sample (with replicate analysis) is sufficient for each stability assessment at each concentration.

To view the presentation, visit the EBF website