A Summary of FDA Guidance for Industry

This guidance establishes standard dissolution methodology and acceptance criteria for highly soluble drug substances formulated in immediate-release (IR) dosage forms. Specifically, they will help your lab:

• Rapidly develop your dissolution methodology during drug product development.
• Facilitate FDA evaluation of the data submitted in your application.

When was the last time you visited the Dissolution Discussion Group?

For 20 years, the DDG has advanced dissolution science through the sharing of expertise. This online forum is the place to:

• Find solutions to your dissolution challenges.
• Instantly access thousands of questions and answers.
• Help—and get help from—your fellow dissolution scientists.

Best of all, membership is free. Register now, and tap into the knowledge of dissolution professionals worldwide.