Vivian A. Gray

Dissolution testing is a critical test for measuring the performance of a drug product.  The dissolution test has been a relatively new analytical technique with equipment modifications and improvements spanning the last decade. The importance of the test has also increased considerably in the last 10 years. It is a quality control tool and an aid to formulation development. Dissolution testing measures change on stability, and is used to establish an in-vitro and in-vivo correlation for some products. 

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About the Presenter:

Vivian A. Gray  is the Head of the Dissolution Group in the Analytical Research and Development Section of DuPont Pharmaceuticals Company in Wilmington, Delaware.  Prior to joining DuPont Pharmaceuticals  Company, she was with the United States Pharmacopeia in Rockville, Maryland. Vivian has spent the last 20 years involved in all aspects of dissolution testing, including regulatory issues, calibration,  dissolution method development and validation, and evaluating new dissolution technology.  She lectures frequently, especially in the areas of calibration, dissolution equipment, and regulatory topics. She was recently elected to the USP Biopharmaceutics Experts Committee. Vivian is a member of the FIP Dissolution Working Group, the PhRMA Dissolution Committee, and the PhRMA Mechanical Calibration Subcommittee. She is a member of the APQ section of AAPS.  She received the American Society of Hospital Pharmacists Research and Education Foundation 1982 Research Award for co-authoring an article on packaging using USP calibrator model tablets and received the FDA Commissioner's Special Citation for involvement in the FDA task force on Gelatin Crosslinking. Vivian is on the Editorial Board of Dissolution Technologies.