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THE RIGHT TREATMENT | FOR THE RIGHT PATIENT | AT THE RIGHT TIME | EVERY TIME
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CDER SBIA to Host Clinical Pharmacology Webinars on Mass Balance, Bioequivalence, and Novel Therapeutics |
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The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) will host multiple webinars of interest to the clinical pharmacology community, including radiolabeled mass balance studies, bioequivalence for immediate-release solid oral dosage forms, and novel therapeutic modalities. Further details and registration information for these upcoming webinars are provided below:
November 12: Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
This activity will discuss the final guidance for industry “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies” (published July 2024) and describe FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs.
Date & Time: November 12, 2024 | 11:00 AM - 12:00 PM ET
November 21: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance
Subject matter experts will provide an update and overview on the final guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” including major changes from the draft guideline and FDA’s current bioequivalence guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.
Date & Time: November 21, 2024 | 1:00 PM - 3:00 PM ET
December 4: Clinical Pharmacology Considerations for Novel Therapeutic Modalities
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.
Date & Time: December 4, 2024 | 1:00 PM - 3:00 PM ET
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The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below and select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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