About this document
Setting Dissolution Specifications by Sri Analysis is a document available to read on EtoBox.
Dissolution testing is used to determine how quickly an active pharmaceutical ingredient is released from a dosage form. This document discusses key aspects of dissolution testing including single point and multi-point dissolution profiles, comparative dissolution testing to assess similarity using the f2 metric, Biopharmaceutics Classification System-based biowaivers, and situations where disintegration testing may substitute for dissolution testing. The document provides guidance on dissolution methodolog
- Author
- Sri Analysis
- Language
- EN