Workshop Report: USP Workshop on Advancements in In Vitro Performance Testing of Drug Products

Overview of the Activities of the USP Expert Panel on New Advancements in Product Performance Testing

“…In-person meetings were held at USP headquarters in Rockville, MD in October and December 2019. The December meeting followed the workshop "Advancements in In-Vitro Performance Testing of Drug Products" where members heard presentations from USP staff and experts on drug performance testing and received input from stakeholders (17). In addition to reviewing information presented at the workshop, the EP discussed emergent technologies in major categories of dosage form performance testing and determined a plan and timeline for incorporating these technologies into a written USP standard.…”

On the importance of physical and mechanical properties of PLGA films during drug release

“…According to studies, the importance of the flow rate on the stress created on stents [16,27], suggests the presence of the flow rate to make similarity with the real condition. For this purpose, the use of shakers, paddle apparatus (USP 2), the flow-through cell apparatus (USP 4), and the reciprocating holder apparatus (USP 7) methods have been some of the methods that have been used to get a more accurate estimate of drug release from drug-eluting stents [28]. Developing a bio-relevant means of testing DES in vitro models under a speed up regime is an important aim of investigations.…”

Performance Tests – Update on USP Activities

“…The panel is composed of experts from the FDA and international representatives from academia and industry. This panel coordinated the USP workshop on "Advancements on In Vitro Performance Testing of Drug Products," held at the USP headquarters in December 2019 (7). The recommendations of this expert panel will be published in future issues of Pharmacopeial Forum.…”