title: Statistical considerations in the establishment of release criteria for allergen vaccines in the USA.
authors.affiliation: Laboratory of Immunobiochemistry, Division of Allergenic Products and Parasitology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, MD, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Slater
authors.forename: A A
authors.initials: AA
authors.lastname: Gam
authors.forename: M D
authors.initials: MD
authors.lastname: Solanki
authors.forename: S H
authors.initials: SH
authors.lastname: Burk
authors.forename: F M
authors.initials: FM
authors.lastname: May
authors.forename: R W
authors.initials: RW
authors.lastname: Pastor
mesh_terms: D000485:Allergens / Q000009:adverse effects / Q000276:immunology*; D004335:Drug and Narcotic Control; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D011506:Proteins / Q000032:analysis; D014481:United States; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000485:Allergens; D011506:Proteins; D014612:Vaccines