Abstract

Bioavailability of drug product can be altered by drug and excipients properties in the formulation and manufacturing process. Sccessful Pharmaceutical development is the perfect understanding of the in vivo and in vitro performance of the dosage form. In-vitro dissolution methods are developed with correlation of In-vivo parameters. In-vitro specifications are set to maintain the consistency and reproducibility of the in vivo characteristics (bioavailability) of the dosage forms.