FDA Webinar: Clinical Pharmacology Considerations for Novel Therapeutic Modalities
Date: December 4, 2024 from 1:00 PM - 3:00 PM ET
From the announcement:
This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. 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.
Our FDA subject matter experts will also address 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. 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.
https://www.fda.gov/drugs/news-events-human-drugs/clinical-pharmacology-considerations-novel-therapeutic-modalities-12042024?utm_medium=email&utm_source=govdelivery
#fda #ClinicalPharmacology #NovelModalities
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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