AAPS Short Course on CD-ROM

Basic Dissolution Testing

About the Course:

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.

Course Contents:

  • General Overview
  • Equipment
  • Sources of Error During Calibration and Sample Testing
  • Utility of Dissolution Testing
  • Selecting Test Conditions and Method Development
  • Method Validation
  • Role of USP in Dissolution Testing
  • FDA Role in Dissolution and Guidances, Other Regulatory Guidances, and Additional Resources

About the Presenter:

Vivian A. Gray was the Head of the Dissolution Group in the Analytical Research and Development Section of DuPont Pharmaceuticals Company in Wilmington, Delaware when this presentation was prepared in 2000. Prior to joining DuPont Pharmaceuticals Company, she was with the United States Pharmacopeia in Rockville, Maryland. Vivian has spent the last 30 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. Vivian has been an invited speaker on 27 occasions, speaking on the subjects of calibration, dissolution equipment, method development, crosslinking, and regulatory topics. She is a proactive participant in the field as demonstrated by 38 publications, writing and revising USP Chapters, initiating change in USP methods, organizing workshops, serving on the USP Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, and the Editorial Board for Dissolution Technologies. She served on the PhRMA Dissolution Committee from 1997 to 2001. Vivian received an American Society of Hospital Pharmacists Research and Education Foundation 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.
In 2002, she formed her own consulting company in dissolution testing and related areas. The company name is V. A. Gray, Consulting, Inc., vagray@rcn.com and www.vagrayconsulting.net, located in Hockessin, DE. She is now Managing Director of Dissolution Technologies, www.dissolutiontech.com.

Who Should Participate:

This CD-ROM Short Course is suitable for anyone who must need to understand dissolution and how dissolution tests are performed, including those involved in formulation, QC, R&D, metrology, and regulation.

Technical Platform and Requirements:

This two-hour course is contained within a standard CD-ROM. Requirements include a 486 or faster PC running Windows 9x, a CD-ROM player, sound card, and speakers. Included on the disk is a copy of PowerPoint 97 Viewer, which is required to view the course content, and which must be installed in the default directory in order to properly utilize the menu-driven program.

Price: $180.00 domestic, $200.00 outside USA. Credit card payment available.

To order online click here. or contact:

Dissolution Technologies
9 Yorkridge Trail
Hockessin, DE 19707
Phone-302-235-0621
Fax-443-946-1264
Email: vgray@dissolutiontech.com