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FDA/CDER – AAPS Public Workshop: Therapeutic Drug Monitoring of Biologics – Current Practice, Challenges and Opportunities

February 26 All day

This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM of some small molecules is commonly performed to sustain target drug levels for efficacy and to minimize safety issues. TDM of large molecule biologics has been reported to improve clinical outcomes in some inflammatory diseases, by ensuring sustained therapeutic levels and reducing the probability of immunogenicity. The potential benefits, limitations, and future considerations for TDM of large molecule therapeutics will be discussed.

10903 New Hampshire Ave
Silver Spring, MD 20993 United States
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