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FDA | CDER | Small Business and Industry Assistance (SBIA)
Clinical Pharmacology Considerations for Novel Therapeutic Modalities
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December 4, 2024 | 1:00 PM - 3:00 PM ET
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The webinar will discuss the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity. To support the growing number of novel therapeutics, the final guidances on oligonucleotide therapeutics and antibody-drug conjugates will be highlighted and described in detail. The presenters will communicate when the recommendations described in the guidances should be considered and what types of assessments are suitable to address the topics listed above during drug development.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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