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The text discusses various methods for determining accuracy in vaccine characterization. These include application of analytical procedures to synthetic mixtures, use of high-performance liquid chromatography, submission of alternative methods and supporting documents, and validation using known standards and quality controls. It also mentions the use of a Quality by Design approach for developing and validating methods for specific vaccines. The importance of analytical evaluation methods in ensuring the safety and efficacy of vaccines is emphasized.
I have found a comprehensive resource discussing the importance of analytical evaluation methods in ensuring the safety and efficacy of vaccines, particularly in relation to method validation, robustness, precision, stability-indicating methods, and in-process testing. However, it may be a good idea to consult regulatory guidelines and scientific publications for specific information on a particular pharmaceutical vaccine's analytical method validation. Do let me know if you need help with anything else!
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