ABSTRACT
The assessment of the quality of an analytical method is far more than a statistical challenge; it is a matter of good ethics and good business practices. Many regulatory documents have been released in the pharmaceutical industry to address quality issues. These are primarily International Conference on Harmonisation (ICH) and Food and Drug Administration (FDA) documents. Those that are related to analytical and bioanalytical method validation (ICH, 1995, 1997; FDA, 2001) suggest that analytical methods must comply with specic acceptance criteria to be recognized as validated procedures. The primary aim of these documents is to require evidence that the analytical methods are suitable for their intended use. Unfortunately, discrepancies exist among these documents with respect to the denition of acceptance criteria, and limited guidance is provided for estimating the performance criteria. Appendix A to this book contains the denitions of various terms used in this chapter.
