Immunogenicity Assessment of Veterinary Therapeutic Protein Drugs
In recent years,therapeutic protein drugs for veterinary have gradually gained increasing attention in drug development.Immunogenicity,which is inherent to these drugs,has emerged as a significant concern due to its potential to alter drug exposure,reduce efficacy,and elicit severe adverse reactions.Consequently,addressing immunogenicity has become a primary focus and challenge in drug development and evaluation.It is essential to comprehensively assess the immunogenicity of veterinary therapeutic protein drugs throughout all stages of drug development,including preclinical studies,clinical trials,and post-market surveillance.This article analyzes the establishment and evaluation requirements of immunogenicity detection methods by referring to technical guidelines on the immunogenicity of therapeutic protein drugs and drawing insights from experiences with evaluation methods used for marketed drugs.Additionally,it explores techniques for conducting clinical immunogenicity research and scrutinizes statistical analysis methods commonly employed to investigate the impact of immunogenicity on pharmacokinetics,pharmacodynamics,and adverse effects.Ultimately,the aim of this article is to provide a valuable reference for the assessment of immunogenicity and clinical research pertaining to therapeutic protein drugs for veterinary.
veterinary therapeutic protein drugsimmunogenicityanti-drug antibodysafety-related analysisefficacy-related analysis
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