书籍

描述

Dissolution testing has been a key tool during drug development stages and for commercial preparation of the dosage forms. At the drug development stage, dissolution testing is used to help in formulation development evaluation of stability, monitoring of product consistency and assessment of the effect of variables (changes in formulation and process parameters) affecting the characteristics of the final product. In case of the commercial products, dissolution testing applied for confirmation of manufacturing and product consistency and evaluation of process variables. With the accumulation of both in vivo and in vitro experience during a product’s development cycle, the dissolution test method should be critically re-evaluated and potentially simplified for final quality control testing.