This two-day workshop will include discussions during the performance of hands-on, step-by-step procedures demonstrating how techniques can be performed in a manner that considers all relevant perspectives and enhances our collective understanding on the topic.
Understanding the measurement of particle size distribution is crucial in developing methods for quality control and demonstrating bioequivalence for complex generic drug products. However, development, optimization, and validation of these methods can be challenging due, in part, to the apparent and deceptive simplicity of particle size analysis.
Attendees will gain theoretical and practical knowledge relevant to performing particle size measurements across diverse and challenging products like emulsions and suspensions. In-person attendees will interact directly with academic experts, instrument vendors, and regulators to delve into use-cases, best practices, and limitations of particle sizing methodologies. Specifically, the workshop will focus on common particle sizing techniques such as dynamic light scattering and laser diffraction, addressing common deficiencies and challenges encountered during quality assessment, bioequivalence studies, and process evaluation.
For more information about these events, as well as other FDA and CRCG collaborative activities, visit http://www.complexgenerics.org/.