538133 Applying Dynamic Similarity Principles to a Narrow Therapeutic Index Drug Powder Blending Process Scale-up: Laboratory Case Studies and Relevant Regulatory Experience

Huiquan Wu, DPA1/OPF/OPQ, FDA/CDER, Silver Spring, MD, Koushik Sowrirajan, DPQR/OTR/OPQ, FDA/CDER, Silver Spring, MD and Masihuddin Jaiqirdar, DPAIII/OPF/OPQ, FDA/CDER, Silver Spring, MD