Importance of Biopharmaceutics in the Overall Development Process

Biopharmaceutics is an integral component of the overall development cycle of a drug. Evaluation begins during the drug discovery process, proceeds through compound selection, preclinical efficacy and safety testing, formulation development, clinical efficacy studies, and postapproval stages. At each stage, biopharmaceuti-cal scientists interface with colleagues in multiple disciplines including discovery chemistry and biology, drug safety assessment, clinical development, pharmaceutical...

Factors Affecting Dissolution

Several physicochemical processes need to be considered along with the drug substance dissolution process to determine the overall dissolution rate of drugs from solid dosage forms under standardized conditions. The dissolution process for a solid dosage form (or a drug product) in solution starts with the wetting and the penetration of the dissolution medium into the solid formulation. It is generally followed by disintegration and or deaggregation into granules or fine particles. However,...