Career Summary:
Vivian has spent the last 40+ years involved in all aspects of dissolution
testing and evaluating new dissolution technology. At the United States Pharmacopeia, she
enjoyed a long career serving first as a bench chemist, supervisor and lastly as a liaison to
various expert USP committees, including the Biopharmaceutics and Dissolution Expert
Committee. In 1997, Vivian joined the DuPont-Merck Pharmaceuticals Company Analytical
Research and Development Section as the Head of the Dissolution Group. In that position, she
gained experience in developing discriminating dissolution methods, writing SOP’s and a variety
of documents, adhering to strict cGMP practices, filing CMC aspects of dissolution methods and
specifications with regulatory agencies and managing a mid-sized laboratory with 10-15
dissolution analysts.
Vivian has been an invited speaker for conferences on 70 occasions (28 of these were
International invitations), lecturing especially in the areas of dissolution method development
and validation, FDA requirements in dissolution testing, troubleshooting dissolution method
problems, and new dissolution technology and dosage forms. She prepares laboratory staff for
audits and inspections, and training for method development, validation, recognizing sources of
error and importance of observations during the test. She is a proactive participant in the field as
demonstrated by 54 publications, including 6 book chapters, contributing to the writing and
revising of USP Chapters, initiating change in USP methods, organizing workshops, served on
the USP Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, on the
PhRMA Dissolution Committee from 1997 to 2001.Vivian has held several offices in the APQ
Section of the AAPS, including Chair in 2008. Vivian 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 has co-
authored a book on dissolution testing called “Handbook of Dissolution Testing”, Third Edition,
published in 2004.
In 2002, she formed her own consulting business in dissolution testing and related areas. The
company name is V. A. Gray, Consulting, Inc, www.vagrayconsulting.net . In June of 2003, she
became Managing Director of Dissolution Technologies, a peer-reviewed journal dealing
specifically with dissolution testing issues, www.dissolutiontech.com
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