ABSTRACT
USP Chapter <1225>, on validation of analytical meth ods, specifically addresses terms and definitions but leaves protocol and methodology open to interpretation. This omission may be intentional so as to allow flexibility in method validation. Laboratory personnel traditionally have been given latitude to do "good science"; however, the term "good science" means different things to differ ent people. This is why the guidelines drafted as a result
of the ICH process have gained importance. The ICH Guideline on Method Validation Methodology (now at Step 4 of the ICH process as of this writing) hints at ex perimental design and protocol. Before outlining an ex perimental design or protocol, however, it is necessary to make some basic assumptions:
1. Selectivity has been previously demonstrated, or is measured and documented during the course of the validation protocol.
