The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products



This guidance provides recommendations to facilitate industry’s development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials

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GMP Conferences by Topics

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