P-097 - EXPLORATION THE POTENTIAL IMPACT OF BATCH-TO-BATCH VARIABILITY OF INHALATION POWDER DRUG PRODUCTS ON PHARMACOKINETIC BIOEQUIVALENCE STUDY POWER.
S. Li1, K. Feng2, J. Lee2, Y. Gong2, F. Wu2, B. Newman2, M. Yoon2, L. Fang2, L. Zhao2, J. Gobburu1; 1University of Maryland, Baltimore, MD, USA, 2US Food and Drug Administration, Silver Spring, MD, USA.