Considerations for Modified Release Products
{"Image DocumentName": "Considerations for Modified Release Products", "Image ImageDescription": "Types: Prolonged release: sustained-, controlled-, extended-release. Delayed release: gastro-resistant. Several studies are required: Single-dose fasted-state cross-over with highest strength. Single-dose fed-state cross-over with highest strength. High-fat meal (time according to SPC or 30 min before drug intake) Multiple-dose fasted state for prolonged release product with a tendency to accumulate (not in FDA) In vitro dissolution studies on alcohol effect (10, 20, 40%)", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}