Chapter 13 - Chromatography in a regulated environment

This chapter describes chromatography in a regulated environment and discusses the regulatory issues surrounding the application of chromatographic techniques to the analysis of drugs in biologic fluids. Significant changes are now evident in the document with respect to the minimum numbers of calibration points that define acceptable calibration curves and that, together with tighter QC batch acceptance criteria, may result in more analytic batches failing, requiring more reanalysis, and impacting on the timings and cost of studies. In addition, documentation requirements, as defined in the guidance, have a major impact and may require significant changes in working practices and current standard operating procedures (SOPs). Chromatographic techniques now cover a broad spectrum of technologies and are thoroughly reviewed. Historically, chromatographic techniques used in bioanalysis have reflected the developing technologies in other industries, for example, food, petrochemical, pesticides, environmental chemicals, and forensic science.