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• W2178725989 abstract "AbstractAn important aspect of drug safety evaluation is determination of potential adverse effects on immune function. Drug-induced immune dysfunction can present as increased susceptibility to infections and tumors (especially virally induced), hypersensitivity reactions such as drug allergy and autoimmunity, and various inflammation-like phenomena. Although immunotoxicity test methods have been developed to assess environmental chemicals, these had not been applied systematically in drug development prior to promulgation of guidance documents by EMA and FDA. EMA and FDA guidances/guidelines differed in certain important respects, and ICH S8 was written to resolve these somewhat conflicting approaches. The key issue resolved in ICH S8 was whether functional immunotoxicity assays should be conducted routinely or when there was a cause for concern. An important result of ICH S8 is that drug developers can no longer ignore signs of compound-related adverse effects on immunity. ICH S8 provides a systematic approach to determining the need for immunotoxicity testing and includes discussion on appropriate methodology. Based on current experience with ICH S8, the issue of including immune function parameters in standard toxicity testing remains unresolved and may be addressed in future revisions of the document. In addition, guidance on unintended immunostimulation may be needed based on recent experiences in clinical drug development.KeywordsAllergic Contact DermatitisLocal Lymph Node AssayExpert Work GroupDrug Safety EvaluationPharmaceutical Manufacturer AssociationThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves." @default.
• W2178725989 created "2016-06-24" @default.
• W2178725989 creator A5056053980 @default.
• W2178725989 date "2013-01-01" @default.
• W2178725989 modified "2023-09-25" @default.
• W2178725989 title "ICH S8: History and Perspectives" @default.
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• W2178725989 doi "https://doi.org/10.1007/978-1-4614-5950-7_12" @default.
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