All Immunogenicity risk assessment articles
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CPD SupplementCreating an integrated summary of immunogenicity report
Introduction The purpose of this case study is to illustrate the creation of an integrated summary of immunogenicity report (ISI) that fulfils the recommendations described in current regulatory guidance for the scope of information needed to facilitate assessment of immunogenicity-related risks to support marketing authorisation of novel and biosimilar versions ...
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CPD SupplementPresentation of immunogenicity-related information in regulatory dossiers
The purpose of this continuing professional development supplement is to explain how an integrated summary report can be created to consolidate the information required for assessment of immunogenicity-related risks of different types of biopharmaceuticals.