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CAGR between 2020 and 2028. To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and methodvalidation.
The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Journal of Pharmaceutical Sciences 109 (2020):1427–1438. Published March 2020. Published March 2020. December 2020. October 2020. Journal of Pharmaceutical Sciences (2021). doi:10.1016/j.xphs.2021.09.046. 2021.09.046.
ANVISA’s analytical methodvalidation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.
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