4.1. Introduction
In the pharmaceutical industry, analytical methods play a vital role in all experiments performed in the development of a drug product. If the quality of an analytical method is doubtful, then the whole set of decisions based on those measures is questionable.
Consequently, 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 ICH and FDA documents. Those that are related to analytical and bioanalytical method validation (ICH, 1995, 1997; FDA, 2001) suggest that analytical methods must comply with specific acceptance ...
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