Particle size is a key factor in understanding how pharmaceutical materials behave. Active pharmaceutical ingredients, excipients, and even the interaction between the two, can be better understood through robust particle size analysis. Join this webinar to discover how Malvern Panalytical’s unique combination of analytical instrumentation and CRO services can take your particle size analysis to the next level. Our experts in particle size analysis, Dr. Anne Virden and Dr. Paul Senior will share their inside knowledge, to show you:· Why you should measure particle size · How particle size affects product bioavailability, uniformity, stability and processability· How to apply the regulatory guidance to help you decide when particle size should be considered as a ‘Critical Material Attribute’ You’ll also see how to measure particle size using laser diffraction - a very popular technique for measuring particle size distributions. You’ll get to see how this technique generates data and how this us used to quantify critical material attributes. You’ll also gain new insights on method development for laser diffraction and discover strategies to ensure the best outcome in getting representative results. In particular, you’ll see how ICH guidance informs method development by focussing on concepts such as Analytical Quality by Design (AQBD) and risk assessments in method development.
Paul Senior - Team Leader – Method Development + Validation
Dr. Anne Virden - Product Manager Micro-Materials
- Who should attend?
Anyone engaged in developing methods for particle size analysis, for example using laser diffraction or image analysis
Anyone who is developing pharmaceutical formulations
Anyone engaged in producing or setting specifications for pharmaceutical raw materials or intermediates
What will you learn?
Learn how particle size analysis is applied in the pharmaceutical industry
Understand the regulatory guidance relating to particle size analysis and method development
Understand how specifications may be set for particle size analysis