AMRI SSCI, LLC (SSCI) – a division of the global contract research, development and manufacturing organization (CDMO) AMRI – provides contract solid-state and analytical testing services
“By combining our dissolution experience for various types of drug products with our expertise in solid state characterization, not only can we conduct the required testing, we can help determine the root cause and propose potential solutions if challenges are encountered in the course of testing,” Adam C. Myers, Ph.D., senior research investigator at AMRI SSCI, LLC told Outsourcing-Pharma.com.
The US Food and Drug Administration (FDA) continually issues new guidance documents as companies aim to bring potential generic drugs to the market, some of which require laboratory-based in vitro bioequivalence testing, explained Myers.
According to 21 CFR 320.24, “bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods.”
In vitro bioequivalence studies are recommended for non-absorbed drugs, topical drugs, in addition to locally acting emulsions and suspensions, Myers said. “In these instances, measuring the amount of the drug absorbed into the system is either not possible, or not clinically relevant,” he explained.
Additionally, though in vivo studies are performed for at least one dose strength of a product requiring multi-strength product equivalency data, other strengths can be evaluated in a non-clinical setting, which Myers said saves time and money.
“While multi-strength product equivalency testing has been around for some time, more products are in the market for which in vitro testing is required, such as various non-absorbed drugs,” he explained.
“The FDA has continued to revise and update guidance documents for many of these products, as more products for which this testing is required have entered the generic space,” Myers added. “Many of these revisions have provided more clarity to establish bioequivalence for these products.”