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AMRI’s SSCI Launches In Vitro Bioequivalence Capabilities

Recommended for non-absorbed drugs, topicals, emulsions and suspensions, and multi-strength product equivalence

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By: Kristin Brooks

Managing Editor, Contract Pharma

SSCI, part of AMRI’s Global Analytical Services, has launched in vitro bioequivalence testing services. 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.

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 recommended by the FDA include: sucroferric oxyhydroxide, sevelamer carbonate and hydrochloride, cholestyramine, colesevelam hydrochloride, and lanthanum carbonate.

“Companies are required to conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in the regulations,” said Adam Myers, Ph.D., senior research investigator, SSCI. “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.”

 

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