University of Wisconsin–Madison

Eccentricity of Method Validation Related to Guidance and Best Practices

When: June 15, 2017 11:00am CST

Today there exists a fairly clear understanding of the intent of the suitability of analytical methods for pharmaceuticals.  ICH, FDA guidance, literature, and USP-published information provide detail specifically for chromatographic methodology and validation and requirements for market approval.  Less information exists for method suitability for early phase development and non-chromatographic methods. Stress testing, method robustness and reproducibility are often performed for registration validation but play an important role in early method development but are not exclusive of validation. How to handle early and late stage suitability and interpret possible inconsistencies in published information will be discussed. This will include case studies, and provide parameters of registration validations as well as applications to drug development stages. 

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