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Added:09/01/2023 14:19
This comprehensive AAPS online training course was developed for those interested in learning more about the field of immunogenicity. This eCourse will provide an in depth overview of beginning through advanced topics for the assessment and interpretation of immunogenicity. As the field of biologic drug development is maturing, a wealth of knowledge has emerged on the topic of immunogenicity from the disciplines of immunology, bioanalytical sciences, protein manufacturing and formulation, and regulatory sciences. This AAPS eCourse utilizes experts from these disciplines to educate the participants in the following areas:
The nature of immune responses to biologically produced therapeutics,
The analytical methods for detection and characterization of antibody responses,
Health authority concerns and expectations,
The analysis of the impact of immunogenicity on safety, efficacy, PK and PD, in preclinical and clinical studies,
The tools and challenges for immunogenicity prediction, mitigation, and reporting during drug development.
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This comprehensive AAPS online training course was developed for those interested in learning more about the field of immunogenicity. This eCourse will provide an in depth overview of beginning through advanced topics for the assessment and interpretation of immunogenicity. As the field of biologic drug development is maturing, a wealth of knowledge has emerged on the topic of immunogenicity from the disciplines of immunology, bioanalytical sciences, protein manufacturing and formulation, and regulatory sciences. This AAPS eCourse utilizes experts from these disciplines to educate the participants in the following areas:
- The nature of immune responses to biologically produced therapeutics,
- The analytical methods for detection and characterization of antibody responses,
- Health authority concerns and expectations,
- The analysis of the impact of immunogenicity on safety, efficacy, PK and PD, in preclinical and clinical studies,
- The tools and challenges for immunogenicity prediction, mitigation, and reporting during drug development.
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