This week, I was in New Orleans attending the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The AAPS Meeting combines a large trade show with technical presentation and poster sessions running in parallel.
At the 2010 AAPS meeting, hot topics included Quality by Design (QbD), Process Analytical Technology (PAT) and the drive towards real-time release for pharmaceutical products. FBRM and PVM technologies were well represented with numerous posters and presentations focusing on their use to understand, optimize and control particle size distribution during drug product formulation. Continue reading →
Over the last five years, FDA and ICH quality initiatives created a paradigm shift in pharmaceutical discovery, development, and manufacturing. At the 17th International Process Development Conference, Christine Moore gave a presentation on the FDA perspective on Quality by Design (QbD) in pharmaceutical development. During her presentation, Christine discussed the advantages that the U.S. Food and Drug Administration (FDA) believes Quality by Design offers, including: Continue reading →