生物药物免疫原性评价的FDA意见综述
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1、会计学1生物药物免疫原性评价的生物药物免疫原性评价的FDA意见综述意见综述Guidance (2014): Immunogenicity Assessment for Therapeutic Protein Product Discusses product and patient risk factors that may contribute to immune response rates.Draft Guidance (2016): Assay Development for Immunogenicity Testing of Therapeutic ProteinsDiscusses
2、 the development and validation of immunogenicity assaysGuidance (2016): Immunogenicity-Related Considerations for Low Molecular Weight HeparinProvides recommendations on addressing impurities and their potential effect on immunogenicity for ANDAsGuidance (2015): Scientific Considerations In Demonst
3、rating Biosimilarity To A Reference ProductDiscusses immunogenicity assays in context of 351(k) pathwayGuidance (2017): Considerations in Demonstrating Interchangeability to a Reference ProductDiscusses immunogenicity studies required for interchangeability in context of 351(k) pathwayDraft Guidance
4、 (2017): ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA OriginDiscusses immunogenicity considerations for recombinant peptides under ANDAGuidance (2014): Immunogenicity Assessment for Therapeutic Protein Product Discusses product and patient risk
5、 factors that may contribute to immune response rates.Draft Guidance (2016): Assay Development for Immunogenicity Testing of Therapeutic ProteinsDiscusses the development and validation of immunogenicity assaysGuidance (2016): Immunogenicity-Related Considerations for Low Molecular Weight HeparinPro
6、vides recommendations on addressing impurities and their potential effect on immunogenicity for ANDAsGuidance (2015): Scientific Considerations In Demonstrating Biosimilarity To A Reference ProductDiscusses immunogenicity assays in context of 351(k) pathwayGuidance (2017): Considerations in Demonstr
7、ating Interchangeability to a Reference ProductDiscusses immunogenicity studies required for interchangeability in context of 351(k) pathwayDraft Guidance (2017): ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA OriginDiscusses immunogenicity considerations for recombinant peptides under ANDA
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