title: Issues in evaluation of bioanalytical method selectivity and drug stability.
abstract: Evaluation of selectivity is one of the most controversial aspects of method validation and application of methods to studies. The focus of selectivity testing should address the question: Above what level will interference significantly impact on study conclusions? Four key issues will be addressed: the statistical relevance of any selectivity test performed; a criterion for significant interference; experimental methods to establish selectivity; and criteria for acceptance. To ensure that compound integrity is maintained throughout the work-up process, statistically meaningful methods of stability evaluation which are associated with specific acceptance criteria are required. Suitable methods for evaluating stability of analyte and/or solutions of analyte, in process stability, processed sample stability, long term stability and freeze-thaw stability, as well as meaningful acceptance criteria, are presented.
authors.affiliation: Analytical Department, Phoenix International Life Sciences, Montreal, Quebec, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Dadgar
authors.forename: P E
authors.initials: PE
authors.lastname: Burnett
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004355:Drug Stability; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations