Abstract
The orange book of FDA shows the therapeutic equivalence between innovator and generic drugs while that in Japan exhibits the equivalence in dissolution. However, the objectives of both books are fundamentally same, since the equivalence in dissolution between two products indicates no significant differences in bioavailability and therapeutic efficacy. The reasons were described in this paper with the history to the birth of Japanese orange book. The Japanese orange book shows generic drugs which were confirmed to be equivalent in dissolution with innovator ones by the reevaluation of the drug quality. It also describes dissolution specifications and dissolution profiles at pH 1.2-6.8, that are useful to understand the quality of drug products and their possible in vivo dissolution behaviors.
