Biorelevant Dissolution: Methodology and Application in Drug Development

Dissolution testing can play an important role in several areas for drug products as a quality control tool to monitor batch-to-batch consistency of drug release from a dosage form and as an in vitro surrogate for in vivo performance that can guide formulation development and ascertain the need for bioequivalence tests. The possibility of substituting dissolution tests for clinical studies has been revealed by the development of...