Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation - Workshop Summary Report
Nikolay Zaborenko, Tessa M. Carducci, Alexander Ryckaert, Haritha Mandula, Matthew J. Walworth, Casey J. Smith, Sandra Suarez‐Sharp, Melanie Dumarey, Sara Manteiga, Sarah Nielsen, Stan Altan, Adriene Malsbury, Beverly Nickerson, Yanmei Lan · Dissolution Technologies · 2022
T he International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Workshop on Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation was held on November 11-12, 2021, virtually using the WebEx video conferencing platform (1).Recordings of all podium talks and panel discussions have been made available by the IQ Consortium (2).The workshop was attended by 256 scientists representing 85 organizations from the pharmaceutical industry and academia as well as regulatory and standards agencies.Figure 1 shows the distribution of workshop registrants by organization type and by experience with dissolution real-time release testing (RTRT), based on their answers to the questionnaire provided electronically during registration.Of the registrants, 86% represented the pharmaceutical industry; additionally, of the 8% who identified as "other," most represented vendors to the pharmaceutical industry (e.g., equipment or software manufacturers, pharmaceutical testing laboratories).