Preclinical Immunogenicity can help understand changes in drug exposure/pharmacokinetics, pharmacodynamics and safety related changes in animal species. The immune response in animals to human proteins is however not translatable to what would occur in patients. The ICH S6 guidance states that immunogenicity measurements should be performed when an impact on PD, unexpected changes in PK and safety findings are noted in animals in IND enabling toxicology studies Goals of this presentation Develop a decision tree to perform immunogenicity based on triggers Further delineate the unexpected changes in PK Streamline immunogenicity assessments through fit for purpose/qualified assays Test animals where impact is observed Gain global regulatory alignment
Learning Objectives:
Become aware of the ICH S6 guidance around preclinical immunogenicity assessments
Discuss the value and relevance of performing preclinical immunogenicity
provide a rational scinece based justification for performing ADA based assessments
