title: Validation of a near-infrared transmission spectroscopic procedure, part A: validation protocols.
abstract: It is possible to devise calibration and validation protocols that enable the ICH guidelines to conform to the specialized requirements of the NIR method of analysis. Some of the required characteristics of evaluation specified by the guidelines, such as accuracy and repeatability, can be applied directly, just as with any other analytical method. Other characteristics are adapted through the novel use of specialized statistics, or through the use of creative methods and procedures to match the recommendations of the guidelines to the unique and specialized requirements of the NIR method.
authors.affiliation: Mark Electronics, 21 Terrace Avenue, Suffern, NY 10901, USA. hlmark@prodigy.net
authors.forename: Howard
authors.initials: H
authors.lastname: Mark
authors.forename: Gary E
authors.initials: GE
authors.lastname: Ritchie
authors.forename: Robert W
authors.initials: RW
authors.lastname: Roller
authors.forename: Emil W
authors.initials: EW
authors.lastname: Ciurczak
authors.forename: Cindy
authors.initials: C
authors.lastname: Tso
authors.forename: Stacy A
authors.initials: SA
authors.lastname: MacDonald
mesh_terms: D000465:Algorithms; D017408:Guidelines as Topic; D010602:Pharmacopoeias as Topic; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000379:methods*