According to the solubility and permeability of drugs, the following Biopharmaceutics Classification System (BCS) is suggested in the literature (Amidon 1995) This classification serves as a foundation for establishing in vitro dissolution specifications and also aids in predicting the probability of achieving a successful in vivo-in vitro correlation (IVIVC). The solubility of a drug is … Read more
PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more
