title: Model format for a vaccine stability report and software solutions.
abstract: A session of the International Association for Biologicals Workshop on Stability Evaluation of Vaccine, a Life Cycle Approach was devoted to a model format for a vaccine stability report, and software solutions. Presentations highlighted the utility of a model format that will conform to regulatory requirements and the ICH common technical document. However, there need be flexibility to accommodate individual company practices. Adoption of a model format is premised upon agreement regarding content between industry and regulators, and ease of use. Software requirements will include ease of use and protections against inadvertent misspecification of stability design or misinterpretation of program output.
authors.affiliation: Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland. shinj@who.int
authors.forename: Jinho
authors.initials: J
authors.lastname: Shin
authors.forename: James
authors.initials: J
authors.lastname: Southern
authors.forename: Timothy
authors.initials: T
authors.lastname: Schofield
mesh_terms: D004355:Drug Stability; D001330:Electronic Data Processing / Q000592:standards; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods* / Q000592:standards; D008962:Models, Theoretical; D012984:Software; D013223:Statistics as Topic / Q000592:standards; D014612:Vaccines / Q000493:pharmacokinetics*; D014944:World Health Organization
chemical_list: D014612:Vaccines