Total 4Articles, Present Page 1/1
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4Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products(Guidance for Industry)Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products(Guidance for Industry)
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Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products(Guidance for Industry).pdf
2024-09-26 -
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3Considerations on the Development of Personalized Neoantigen-Targeted Therapy Products(Guidance for Industry)Considerations on the Development of Personalized Neoantigen-Targeted Therapy Products(Guidance for Industry)
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Considerations on the Development of Personalized Neoantigen-Targeted Therapy Products(Guidance for Industry).pdf
2024-09-26 -
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2Compilation of Analysis Methods on the Determination of Mutagenic Impurities in drug substances or drug productsMFDS publishes a compilation of analytical methods to support drug manufacturers' efforts to control mutagenic impurities incuding nitrosamines.This document is intended to providepharmaceutical industry with the information about the analysis methods for the determination of mutagenicimpurities in ...
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230811_MFDS_Compilation of Analysis Methods on the Determination of Mutagenic Impurities in drug substances or drug products.pdf
2023-08-11 -
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1Analytical Methods for the Determination of Mutagenic Impurities in Drug Substances or Drug ProductsThis document is intended to provide pharmaceutical industry with the information about the analysis methods for the determination of mutagenic impurities in drug substances or drug products. The analysis methods in this document were developed and validated in the research studies funded by MFDS. B...2023-01-27
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