ABSTRACT
Drugs derived from biological sources such as vaccines, sera, therapeutic proteins, and antibodies are large molecules and structurally difcult to characterize, have side effects like immunogenic responses, and have stability proles that are difcult to predict and structure-activity relationship that is ill dened, all leading to realization that the bioequivalence of these products cannot be demonstrated by the currently used methods used for chemically derived drugs (small molecule).
