title: Incurred sample reanalysis: failures in macromolecule analysis--insight into possible causes.
abstract: "Good people are good because they've come to wisdom through failure" - William Saroyan. Since the Crystal City III conference considerable effort has been spent defining what constitutes appropriate incurred sample reanalysis analysis. While what to do, such as the number of samples and acceptance criteria, is becoming generally recognized, it is important to step back and examine as a community what we are learning by this exercise. Through discussions with colleagues throughout the industry who specialize in macromolecule analysis, it was clear most incurred sample reanalysis testing passes without issue, but in some cases there are lessons to be learned. We thank all who would share, in confidence, their failures as well as their investigations so as a community we can learn. We would suggest scientist can be substituted for people in the quote from William Saroyan.
authors.affiliation: Sailstad & Associates, Inc. 6 Porchlight Court, Durham, NC 27707, USA. sailstad@aol.com
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Sailstad
authors.forename: Brent E
authors.initials: BE
authors.lastname: Salfen
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bowsher
mesh_terms: D016477:Artifacts; D001681:Biological Assay; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D046911:Macromolecular Substances / Q000032:analysis / Q000737:chemistry; D011340:Problem Solving; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents / Q000032:analysis*; D013048:Specimen Handling / Q000379:methods*; D013997:Time Factors; D054928:Validation Studies as Topic
chemical_list: D046911:Macromolecular Substances; D012997:Solvents