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In recent years, peptide therapeutics have garnered significant attention due to their remarkable potential in treating a wide range of human diseases, including diabetes, obesity, and cancer. Over 100 peptide drugs have been approved and marketed globally, highlighting their growing importance in modern medicine. However, the development of novel peptide therapeutics presents notable challenges. Their larger size and structural complexity pose unique difficulties in bioanalysis, such as non-specific binding, assay sensitivity, stability, and immunogenicity evaluations. Additionally, the diverse submodalities of therapeutic peptides result in distinct ADME properties, further complicating their preclinical development. Given the lack of specific guidelines and technical standards for non-clinical research on peptide drugs, a case-by-case approach is essential for preclinical toxicological evaluations. This involves designing studies based on the specific regulations outlined in various guidelines while considering the unique characteristics of each peptide drug. To address these challenges and accelerate the development process, comprehensive preclinical development, DMPK, and bioanalytical solutions are crucial.

This webinar will cover non-clinical safety evaluation strategies, DMPK assessment including radiolabeling synthesis and ADME studies, as well as solutions for bioanalytical challenges such as non-specific binding and immunogenicity, providing researchers with essential knowledge and tools.