SSCI announced the availability of in vitro bioequivalence testing services. A successfully developed generic drug product is expected to be pharmaceutically equivalent to its reference listed drug (RLD), bioequivalent to the RLD, and, consequently, therapeutically equivalent. According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo and/or in vitro testing.
“Companies are required to conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in the regulations,” Adam Myers, Ph.D., senior research investigator, SSCI said. “SSCI provides cGMP dissolution support for APIs and a wide variety of dosage forms in various media systems, including biorelevant media, to meet these regulatory requirements. Our experience in comparative dissolution, combined with a variety of technologies and techniques and expertise in solid-state chemistry, positions us well for in vitro bioequivalence testing of various drug products. We have years of expertise that enables us to develop and validate appropriate methods for accurate quantitation in bioequivalence studies and solve complex dissolution issues for our customers rather than just identify a problem.”
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 FDA include: sucroferric oxyhydroxide, sevelamer carbonate and hydrochloride, cholestyramine, colesevelam hydrochloride, and lanthanum carbonate.