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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

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Session 9C: Clinically Relevant Specifications: Technical Considerations and Regulatory Expectations

Session Chair(s)

Nagesh Bandi, PhD

Nagesh Bandi, PhD

Executive Director

Merck & Co., Inc, United States

Due to the critical role that dissolution plays in the bioavailability of a drug, in vitro dissolution can serve as a relevant predictor of the in vivo performance of the drug product. There is growing evidence that clinically meaningful dissolution specifications will minimize variability to the patient and therefore will optimize drug therapy. This session will discuss the relevant CMC and clinical pharmacology-related factors that should be considered in developing a clinically relevant dissolution method and specifications. In addition, the regulatory expectations and considerations will be illustrated.

Speaker(s)

Novel Approaches to Better Understand Drug Product Design and Testing

Phil D Floyd, PhD

GlaxoSmithKline, United States

Head, Analyical Development

Strategies for Ensuring Dissolution and Clinical Performance

Vivek Purohit, PhD

Pfizer, Inc., US, United States

Director

Clinically Relevant Specifications: FDA Perspective

Angelica Dorantes, PhD, MSc

FDA, United States

Biopharmaceutics Branch Chief (acting), Office of Pharmaceutical Quality, CDER

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