title: Current industrial practices and regulatory requirements to assess analyte and reagent stability using ligand-binding assays.
abstract: Specific guidelines on bioanalytical method validation for drug development support are recommended by regulatory agencies. Regarding stability assessment, US FDA states that 'Stability procedures should evaluate the stability of the analytes during sample collection and handling, after long-term (frozen at the intended storage temperature) and short-term (bench-top, room temperature) storage, and after going through freeze and thaw cycles and the analytical process'. Additional regulatory considerations are discussed including topics such as analyte and reagent stability. This article reviews the regulatory requirements as issued by the USA (FDA), Europe (EMA) and Japan (MHLW), for stability studies where bioanalytical methods are used to support drug development programs and summarizes the current industry standard for conducting stability studies when utilizing ligand-binding assays.
authors.affiliation: Pharmacokinetics & Drug Metabolism Department, Amgen Inc., MS: 30E-3-C, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Radix BioSolutions, 111 Cooperative Way, Georgetown, TX 78626, USA.
authors.forename: William
authors.initials: W
authors.lastname: Nowatzke
authors.affiliation: Pharmacokinetics & Drug Metabolism Department, Amgen Inc., MS: 30E-3-C, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods; D055808:Drug Discovery / Q000379:methods*; D004355:Drug Stability; D005060:Europe; D006801:Humans; D007202:Indicators and Reagents / Q000737:chemistry / Q000378:metabolism; D007564:Japan; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000097:blood / Q000737:chemistry / Q000378:metabolism; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations