後発医薬品の製剤学的同等性の検討(2)

概要

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As for generic drug, there are acknowleged a few presentation materials of application for production approval to Ministry of Health and Welfare, compared with pioneer drug. In particular, bioequivalence between these products wasn't taken out duty in old application products, and they have been used. Thus, we examined the pharmaceutical equivalence of pioneer and generic drugs (4 products), i. e. timepidium bromide and ketotifen fumarate. Each product conforrned to the standard weight deviation, disintegration and quantitative tests according to the Japanese Pharmacopoeia ( 12 th Ed). However, significant differences were found among the products in the dissolution test for timepidium bromide. The dissolution test Is conducted to ensure that the quality of medical supplies meets a fixed standard, and to maintain bioequivalence. Poor results in the dissolution test often result in an attenuation of bioavailability, and may produce differences in absorption compared with other products. Therefore, it is suggested that one product which exhibits a different dissolution profile to other compounds may possess differnt pharmacokinetics.
1997-10-10