关于控股股东部分股权解除质押的公.pptVIP

Parametric Tolerance Interval Test for Delivered Dose Uniformity (DDU) Working Group Update Moheb M. Nasr, Ph.D. Office of New Quality Assessment (ONDQA, CDER, FDA) Advisory Committee of Pharmaceutical Science October 25, 2005 Contents Background Information DDU Test Approaches Desired Outcome of DDU Efforts for IPAC-RS General Agreements – FDA Perspective Where are we today? Case Studies from NDAs and/or active candidates in late development Summary FDA Proposal Background Information Pre-1998; Walter Hauck (SGE), proposes to use PTIT for delivered dose uniformity testing to FDA Hauck’