Scientific Publications by FDA Staff

Arb Paul Ehrlich Inst Bundesamt Sera 2006;(95):191-3

Recombinant and modified allergens: the U.S. perspective.

Rabin RL

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.