title: Immunotherapy preparation guidelines, rules, and regulation.
abstract: Allergen immunotherapy has been used to treat allergic diseases for more than 100 years. In the U.S., the preparation of diagnostic and therapeutic extracts requires the cooperation of the extract manufacturer, who provides the individual allergen concentrates, and the practicing physician who formulates, dilutes, and administers the final patient-specific treatment extract. The guidelines, rules, and regulations for these activities have been established and continue to be developed as progress is made. The molecular characterization and standardization of allergenic extracts has allowed for improvements in defining the potency of these products. In turn, these advances have led to improved dosing regimens and formulation practices. This review will describe in detail some of these interactions and will identify issues that require more attention.
authors.affiliation: Greer Laboratories, 639 Nuway Circle, Lenoir, NC 28645, USA. esch@greerlabs.com
authors.forename: Robert E
authors.initials: RE
authors.lastname: Esch
authors.forename: Greg A
authors.initials: GA
authors.lastname: Plunkett
mesh_terms: D000485:Allergens / Q000627:therapeutic use*; D003429:Cross Reactions; D003888:Desensitization, Immunologic / Q000592:standards*; D004339:Drug Compounding / Q000592:standards; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology / Q000628:therapy; D017410:Practice Guidelines as Topic; D012015:Reference Standards; D013242:Sterilization / Q000592:standards
chemical_list: D000485:Allergens