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[DOI] [PMC free article] [PubMed] [Google Scholar] 214.Murphy MB, Blashki D, Buchanan RM, Fan D, De Rosa E, Shah RN, et al

FDA has published a technical specifications document entitled "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug," intended to help support the regulatory evaluation of immunogenicity data