Proveris Scientific has announced the availability of new testing services that “support the FDA’s newly released draft guidance on beclomethasone dipropionate that promotes alternate in-vitro studies in lieu of clinical endpoint.”
According to Proveris, the new services are “Based on an innovative new proprietary technology” and “have been developed in collaboration with key industry leaders.” New aerosolization, regional deposition, and bioavailability testing is performed “under more human realistic conditions than existing methods,” the company said.
The new draft guidance suggests that for beclomethasone dipropionate, “Additional supportive in vitro studies may include, but are not limited to, (i) more predictive APSD testing using representative mouth-throat models and breathing profiles, (ii) characterization of emitted aerosol sprays with respect to velocity profiles and evaporation rates, (iii) dissolution, and (iv) morphology imaging comparisons, including characterization of the full range of residual drug particle sizes.”
Proveris Scientific VP of Technical Services Alberto Correia commented, “We are very excited to offer our customers access to this new technology. We believe we will provide our customers tremendous insight into the performance of their products and enable a new approach to IVIVC.”
