title: Bioanalytical method development and validation: Critical concepts and strategies.
abstract: Bioanalysis is an essential part in drug discovery and development. Bioanalysis is related to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples and it involves several steps from sample collection to sample analysis and data reporting. The first step is sample collection from clinical or preclinical studies; then sending the samples to laboratory for analysis. Second step is sample clean-up (sample preparation) and it is very important step in bioanalysis. In order to reach reliable results, a robust and stable sample preparation method should be applied. The role of sample preparation is to remove interferences from sample matrix and improve analytical system performance. Sample preparation is often labor intensive and time consuming. Last step is the sample analysis and detection. For separation and detection, liquid chromatography-tandem mass spectrometry (LC-MS/MS) is method of choice in bioanalytical laboratories. This is due to high selectivity and high sensitivity of the LC-MS/MS technique. In addition the information about the analyte chemical structure and chemical properties is important to be known before the start of bioanalytical work. This review provides an overview of bioanalytical method development and validation. The main principles of method validation will be discussed. In this review GLP and regulated bioanalysis are described. Commonly used sample preparation techniques will be presented. In addition the role of LC-MS/MS in modern bioanalysis will be discussed. In the present review we have our focus on bioanalysis of small molecules.
authors.affiliation: Department of Chemistry, Amirkabir University of Technology, Tehran, Iran.
authors.forename: Mohammad Mahdi
authors.initials: MM
authors.lastname: Moein
authors.affiliation: Department of Enviromental Science & Analatical Chemistry, Stockholm University, SE10691, Stockholm, Sweden.
authors.forename: Aziza
authors.initials: A
authors.lastname: El Beqqali
authors.affiliation: Department of Enviromental Science & Analatical Chemistry, Stockholm University, SE10691, Stockholm, Sweden. Electronic address: Mohamed.abdel-rehim@aces.su.se.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Rehim
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D035843:Biomedical Research; D002853:Chromatography, Liquid; D055808:Drug Discovery; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D053719:Tandem Mass Spectrometry
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations
keywords: Bioanalysis; Bioanalytical method development; GLP; Liquid chromatography; Method validation; Sample preparation; Tandem mass spectrometry