Современные подходы к оценке генерических лекарственных средств при их регистрации (обзор)

At present, the quality of generic drugs for registration in the Russian Federation is checked by studying their bioequivalence. According to FDA and WHO guidelines, some generic drugs can be registered on the basis of only in vitro data (dissolution test) without testing for their bioequivalence in vivo. For such a simplified scheme of registration, a biowaiver procedure is developed, which is based on a biopharmaceutical classification system.