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US Food and Drug Administration's 2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
 
The US Food and Drug Administration's 2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting will be held at:

Omni Shoreham Hotel*
2500 Calvert St. NW
Washington, DC 20008

*The Omni Shoreham Hotel is located directly across the street from the Marriott Wardman Park Hotel, the official hotel of the 2017 Annual Meeting.  
 
Description
The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The Advisory Committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas: approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug's lifecycle and mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in vitro proarrhythmia assay will be discussed as an exemplar.
 
The Advisory Committee meeting is open to all interested individuals. Registration for the ASCPT Annual Meeting is not required to attend the Advisory Committee meeting. Scientists interested in presenting data, information, or views, orally or in writing, should view the Federal Register or contact Jennifer Shepherd at ACPS-CP@fda.hhs.gov for details. 
 

528 N Washington St, Alexandria, VA 22314 |  Ph: 703.836.6981 |  info@ascpt.org