Hey, I would like to ask for expert guidance regarding the duration requirement of BE.
Drug API: BCS Class 2,
Dosage form: Immediate release tablet.
half life: 18 hours
study design required: 2 period cross-over
how will i estimate the duration required?
Please follow the ICH M13(A) - Guidelines on BIOEQUIVALENCE FOR IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS, Final version, Adopted on 23 July 2024.
The link to the above guideline is given below,
[BIOEQUIVALENCE FOR IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS](https://ICH M13A)
You can also refer to the product-specific BE Guidelines by USFDA.
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