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Archive for July, 2007Guidelines On The Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins come into effectJuly 31st, 2007Biomonitor’s work within immunogenicity of therapeutic proteins has been recognized by the European Medicines Agency (EMEA) EMEA have formulated a set of “Guidelines On The Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins” that came into effect on 31. july 2007. An abstract of the guidelines on immunogenicity is provided below and full document is available for download. In a draft publication, Guidelines on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins, the European Medicines Agency (EMEA) now recognizes Immunogenicity as an essential element to investigate when treating patients with therapeutic proteins and peptides. 
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