The absorption of drug is dependent on the release if drug from dosagt form and it's solubilization in physiological media. These factors can be simulated in vitro using dissolution profiling. USFDA has laid down the requirements and acceptance criterua for dissolution similarity.
Dissolution similarity is helpful to support post approval changes in drug products and the requirements of bio study.
#tablet
#dissolution
#dissolutiin similarity
#USFDA
#F2 Calculation
#dissolution profile
#bio-waiver
#drug release