Scope of the Two-Day Workshop
Understanding the measurement of particle size distribution is crucial in developing methods for quality control and demonstrating bioequivalence (BE) 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.
This two-day workshop will include in-person discussions during hands-on, step-by-step demonstrations showing how techniques can be performed in a manner that aligns all relevant perspectives, and enhances our collective understanding on the topic. 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 (DLS) and laser diffraction, addressing common deficiencies and challenges encountered during quality assessment, BE studies, and process evaluation.
Information on the Call for Volunteer Vendors
The goal of the FDA-CRCG workshop is to demonstrate how the two widely utilized particle sizing techniques, dynamic light scattering and laser diffraction, can effectively measure both simple and challenging samples, which often pose obstacles in generic drug development.
Participating vendors will receive samples from CRCG three to six months in advance of the workshop. Our goal is for vendors to document their method optimization process, providing a walkthrough of sample data from the initial measurement attempts to the final results. We’re particularly interested in identifying the difficulties encountered when first analyzing a sample and how vendors approach solving these problems. These challenges are often underreported, so we want vendors to explore and document the steps and corrective measures necessary to overcome them and achieve consistent results. Vendor-generated measurement data will be shared with CRCG one month before the workshop to assist in preparing workshop materials.
Additionally, participating vendors will have the opportunity for rapid-fire talks, lasting approximately 10-20 minutes (exact length depends on the number of participating vendors). We encourage these presentations to focus more on the technology and its applications rather than promotional materials. The talks should avoid discussing specific samples, as our goal is for participants to engage directly in the optimization process through hands-on experience, rather than hearing about it secondhand from the vendor.
A kickoff meeting will be scheduled with potential vendors to ensure clear communication of expectations for the lab demo, to address any questions and ensure everyone is on the same page.
Interested vendors are requested to submit a Letter of Intent by 11:59 pm ET on Monday, September 16, 2024. LOI should be emailed to info@complexgenerics.org.
LOI should summarize their interest in supporting this workshop, and include information on the instrument that would be used for the in-person demonstration i.e., make, model, etc.; number of instruments that could be brought to the event location for the live lab demo; and resources that will be needed onsite during the live lab demonstration i.e., power supply, water supply, etc. LOI should also indicate your availability for the live demonstration on April 29-30, 2025, and setup on Monday, April 28, 2025 at The Universities at Shady Grove (Rockville, Md.).