Chapter 8 - Drug product performance and scale-up process approval changes

Abstract

Drug product performance studies are used in developing new and generic drug products. There are several concerns to be addressed by a pharmaceutical company during the development of a drug product, starting from the active pharmaceutical ingredient to the robust production process. The assessment of the formulation is important because bioavailability (BA) is linked to both the pharmacodynamic response and the adverse events. Therefore the consistency of a drug product which is related to clinical safety and effectiveness is achieved through drug product performance measures. Therefore this chapter discusses general information about the dissolution profile as a measure of in vitro drug product performance, in vivo performance including BA and bioequivalence (BE) studies. This chapter also discusses on biopharmaceutics classification system (BCS) that can be used as a predictor of the product’s performance, in vitro–in vivo correlation, biowaivers, scale-up, and postapproval changes in accordance with regulatory guidelines. The focus of this chapter is primarily on the performance of solid oral drug products.