About this document
FDA Dissolution Methods Overview by Asma Hadjimi is a document available to read on EtoBox.
The document discusses FDA dissolution methods for quality control in drug products, emphasizing the importance of product-specific methods and the use of the FDA Dissolution Database as a starting point for development. It highlights that water is not a recommended dissolution medium and outlines the criteria for method validation. The presentation aims to facilitate generic product availability through product-specific guidances.
- Author
- Asma Hadjimi
- Language
- EN