AMRI Launches In Vitro Bioequivalence Testing
SSCI, part of analytical services at AMRI, a contract research, development, and manufacturing organization, has launched in vitro bioequivalence testing services.
A developed generic-drug product is expected to be pharmaceutically equivalent to its reference listed drug (RLD), bioequivalent to the RLD, and, consequently, therapeutically equivalent, notes the company. AMRI said according to the Code of Federal Regulations, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo and/or in vitro testing.
In vitro bioequivalence studies are recommended for non-absorbed drugs, topical drugs, locally acting emulsions and suspensions as well as multi-strength product equivalency. A few of the products for which in vitro bioequivalence studies are exclusively recommended by the US Food and Drug Administration include: sucroferric oxyhydroxide, sevelamer carbonate and hydrochloride, cholestyramine, colesevelam hydrochloride, and lanthanum carbonate.