... or microorganisms to screen their spectrum of605 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.baseline setup, ... (e.g.,dose-proportionality studies), salt/formulation selection (pharmaceutical research and development), clinical PK studies, and post-marketing surveil-lance (Figure 13 -14) [50–53]. Hence, intra- and ... treated as a whole (for more details see www.fda.gov; General Principles of Software Validation;Final Guidance for Industry and FDA Staff, January 11, 2002). The PQ isusually performed prior to...