Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to provoke an immune response.
In this chapter, Certara Associate Director of Clinical Pharmacology, Morena Shaw discusses explains the details of crafting an Integrated Summary of Immunogenicity (ISI). The FDA requires drug developers to provide ISIs for all new 351(a) and 351(k) BLA submissions.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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