About this document
Bioequivalence Guidelines for Oral Dosage by kayes_abu is a document available to read on EtoBox.
This document provides guidelines for assessing bioequivalence of oral solid dosage forms that differ in strength but are the same in active ingredient, dosage form, therapeutic indication, and dosage regimen. It outlines three levels (A, B, C) of formulation change between test and reference products and the tests required for bioequivalence assessment depending on the level of change. For level A, dissolution tests are sufficient to determine bioequivalence, while for levels B and C, in vitro dissolution
- Author
- kayes_abu
- Language
- EN