title: Recombinant and modified allergens: the U.S. perspective.
abstract: Since allergenicity and antigenicity (potency) are no longer equivalent, one must scientifically justify modifications and demonstrate (a) loss of allergenicity by standard methods, (b) potency with animal and clinical studies, as well as surrogate markers for clinical efficacy, and (c) biochemical and biologic stability.
authors: US Food and Drug Administration, Center for Biologics Evaluation, Rockville, MD 20852, USA.
authors: Ronald L
authors: RL
authors: Rabin
mesh_terms: D000485:Allergens / Q000276:immunology*; D000818:Animals; D003888:Desensitization, Immunologic / Q000592:standards*; D006801:Humans; D011994:Recombinant Proteins / Q000276:immunology*; D051193:Toll-Like Receptors / Q000502:physiology
chemical_list: D000485:Allergens; D011994:Recombinant Proteins; D051193:Toll-Like Receptors