CPD supplements

Creating an integrated summary of immunogenicity report

By Paul Chamberlain2020-05-01T13:43:00

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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 of ...

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