SSCI, part of AMRI’s Global Analytical Services, today 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,” explains 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. 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 oxyhydroxide¹, sevelamer carbonate² and hydrochloride³, cholestyramine⁴, colesevelam hydrochloride⁵, and lanthanum carbonate⁶.
SSCI has recently developed experimental conditions for conducting the required phosphate binding studies for sucroferric oxyhydroxide bioequivalence evaluation. At the upcoming 2017 AAPS Annual Meeting being held Nov. 12-15, 2017 in San Diego, SSCI will be featuring a poster presentation entitled, “In Vitro Bioequivalence Method Development for Sucroferric Oxyhydroxide,” on November 14, from 4:00 pm – 5:00 pm, in Forum No. 2, at the San Diego Convention Center.
¹ FDA. “Draft Guidance on Sucroferric Oxyhydroxide.” Recommended March 2015.
² FDA. “Draft Guidance on Sevelamer Carbonate.” Recommended September 2008; Revised May 2010; June 2011; September 2015.
³ FDA. “Draft Guidance on Sevelamer Hydrochloride.” Recommended September 2008; Revised July 2009; May 2010; August 2010; August 2011; December 2014.
⁴ FDA. “Draft Guidance on Cholestyramine.” Recommended September 2011; Revised November 2011; March 2012; June 2015.
⁵ FDA. “Draft Guidance on Colesevelam Hydrochloride.” Recommended August 2010; Revised July 2011; March 2012; June 2013; January 2016.
⁶ FDA. “Draft Guidance on Lanthanum Carbonate.” Recommended August 2011; Revised November 2013; May 2017