Introduction to calibration curves in bioanalysis

Edward Brewer leads laboratory operations for both discovery and GLP groups at Tandem Labs' New Jersey facility. He joined Tandem Labs in 1999 and has been involved in bioanalytical MS since receiving his masters degree in 1986. His expertise comes from experience within forensic toxicology, large pharmaceutical companies and contract research organizations. Ed Brewer's research interests involve quantitation of pharmaceutical-based products from biological matrices with high-throughput assays. Analytical standards are used in bioanalytical analysis for the quantitative measurement of large and small molecules in the pharmaceutical industry. This article will introduce the reader to the common, acceptable practices for the use of calibration curves in chromatographic and ligand-binding assays. The discussion presented is a combination of regulatory requirements and the authors' experience in performing bioanalysis. While all possible techniques are not covered, generally acceptable practices are described to serve as a starting point for novice practitioners.