title: New perspectives and lessons learned in the identification of impurities in drug development.
abstract: Within the pharmaceutical industry, the rapid identification, elucidation and characterization of synthetic or process impurities or degradants form an intense and a comprehensive undertaking. Advances in laboratory hardware and software are changing the way in which scientists work together to help resolve impurities in a quick and efficient manner. Although the industry trend toward externalization and outsourcing of development tasks provides a cost-effective method, the demand for improved productivity in laboratory workflows in drug development continues to be a high priority. This brings a need for new approaches for communication, collaboration and data management.
authors.affiliation: Advanced Chemistry Development, 8 King Street East, Suite 107, Toronto, ON M5C1B5, Canada. Electronic address: ryan.sasaki@acdlabs.com.
authors.forename: Ryan R
authors.initials: RR
authors.lastname: Sasaki
authors.affiliation: Advanced Chemistry Development, 8 King Street East, Suite 107, Toronto, ON M5C1B5, Canada.
authors.forename: Graham
authors.initials: G
authors.lastname: McGibbon
authors.affiliation: SCYNEXIS, 3501 Tricenter Blvd, Durham, NC 27713, USA.
authors.forename: Mike S
authors.initials: MS
authors.lastname: Lee
authors.affiliation: Mileston Development Services, P.O. Box 178, Newtown, PA 18940-0178, USA.
authors.forename: Clare L
authors.initials: CL
authors.lastname: Murray
authors.affiliation: Bruce Pharr, Saratoga, CA, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Pharr
mesh_terms: D003299:Cooperative Behavior; D004340:Drug Contamination / Q000517:prevention & control; D055808:Drug Discovery; D048088:Informatics; D007753:Laboratories; D012106:Research