Can I read Bead Size Guidance for Sprinkle Drugs on EtoBox?
Bead Size Guidance for Sprinkle Drugs by Allison V. Moffett is a document available to read on EtoBox.
What is Bead Size Guidance for Sprinkle Drugs about?
This FDA guidance provides recommendations for the size of beads in drug products labeled for sprinkle administration. It recommends that beads be no larger than 2.5 mm, with up to 10% allowed between 2.5-2.8 mm. For products listing enteral tube administration, the entire contents should be able to pass through the tube without occlusion. Bioequivalence studies may be needed depending on the bead size.
- Author
- Allison V. Moffett
- Language
- EN