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. Studies to establish bioequivalence are conducted both in vivo and in vitro. In vitro bioequivalence studies are recommended for non-absorbed drugs, topical drugs, locally acting emulsions and suspensions, as well as multi-strength product equivalency.
SSCI provides cGMP dissolution support for APIs and a wide variety of dosage forms in various media systems, including biorelevant media. We have capability with various USP dissolution apparatus options, along with various diffusion experiments, using a variety of chromatographic and spectroscopic detection techniques. Our experience in comparative dissolution, combined with our expertise in solid-state chemistry, positions us well for in vitro bioequivalence testing of various drug products.
Many different products require in vitro bioequivalence evaluation. A few of those products include:
- Colesevelam Hydrochloride
- Lanthanum Carbonate
- Sevelamer Carbonate
- Sevelamer Hydrochloride
- Sucroferric Oxyhydroxide
Additional compounds requiring in vitro bioequivalence testing can be found here.
SSCI has a wide variety of instrumentation to support in vitro bioequivalence testing, including:
- USP Dissolution
- Apparatus 1
- Apparatus 2
- Apparatus 5
- Franz vertical diffusion cells
- Side-by-side diffusion cells
- HPLC, UPLC, Ion Chromatography (IC), and Size Exclusion (SEC)
- Detection by UV, MS, RID, MALS, CAD, and Fluorescence
SSCI provides cGMP support to meet the FDA requirements for in vitro bioequivalence testing of a variety of dosage forms. Combined with an excellent regulatory record, SSCI is the clear choice for a partner in testing for approval of new generic drug products requiring in vitro bioequivalence testing.