martes, 28 de febrero de 2017

FDA Announces Pharmaceutical Science & Clinical Pharmacology Advisory Committee Meeting March 15, 2017

The Food and Drug Administration will hold a public meeting of the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee. The committee will discuss strategies, approaches, and challenges in model-informed drug development for new and generic drugs. The morning session of this advisory committee meeting will be of particular interest to those in the generic drug industry as it will cover approaches and evidentiary information needed for applying physiologically-based pharmacokinetic (PBPK) modeling and simulation during generic drug development as well as to support abbreviated new drug applications (ANDA) regulatory review. In recent years, PBPK modeling has been utilized in generic drug product development, ANDA regulatory review and product specific guidance development to assess biopharmaceutical performance in support of bioequivalence studies in ANDAs.
The PSCP Advisory Committee meeting will be held at the Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW, Washington, DC 20008 on March 15, 2017, from 7:30am to 3:45pm. The Advisory Committee meeting will be held in conjunction with the American Society for Clinical Pharmacology and Therapeutics 2017 Annual Meeting.
The Advisory Committee meeting will be open to the public. In addition, written comments can be sent to the docket (FDA–2010–N–0067), which will close on April 14, 2017.
Meeting materials will be available prior to the meeting at:

Additional information about this meeting, including instructions for submitting either electronic or written comments, is available at:

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