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Sampling time recommendations during fed state gastrointestinal dissolution testing
Recommended sampling time points for a formulation that has not previously been explored in the fasted state biorelevant medium are:
For FEDGAS: 5, 10, 20, 30, 45, 60, 90, 120, and 180 minutes
For FeSSIF-V2: 5, 10, 20, 30, 45, 60, 90, 120, and 180 minutes
These time points help evaluate how the drug product behaves (dissolution and stability) in the biorelevant medium over appropriate physiologically relevant time frames for the fluid that is being simulated.
For immediate-release dosage forms, in FeSSIF-V2 carefully observe and record the disintegration behaviour during the first 2 to 3 minutes. Observation in FEDGAS is not feasible because the medium is opaque.
