19. December 2015 The concept of Quality by Design is of increasing importance in the pharmaceutical industry, especially in the development of biotechnologically produced…

The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters, of their variability and their interactions. Microcrystalline cellulose…

27. April 2015 29/04/2015 09:35 - 09:55 - IPEC Europe, Room C Liz Meehan Principal Scientist in Material Attributes and Product Performance - Astra Zeneca

17. September 2014 The article is in German and about QBD factors in pharmaceutical excipients with example on pellets. If somebody is interested I can check for a translation. The author Gudrun Ding from IPC Dresden will…

"Quality by Design for the Scientists in the Benches and Trenches" QbDWorks is a community of professionals, working in Life Science advancing Quality by Design (ICH Q8 R2) If you’re new to Quality by…

Rivaroxaban (RXN) finds use in the management of pulmonary embolism and deep vein thrombosis. Its poor solubility (5–7 µg/mL) and P-gp-mediated efflux from intestinal lining limits the oral application of RXN. This work assessed the impact…

Microcrystalline cellulose (MCC) of different grades from different manufacturers differ in particulate and powder properties significantly. The choice of MCC is important to the development of a tablet formulation with satisfactory…